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Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma

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ClinicalTrials.gov Identifier: NCT02306161
Recruitment Status : Recruiting
First Posted : December 3, 2014
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This randomized phase III trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Monoclonal antibodies, such as ganitumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination chemotherapy is more effective with or without ganitumab in treating patients with newly diagnosed Ewing sarcoma.

Condition or disease Intervention/treatment Phase
Metastatic Ewing Sarcoma Metastatic Malignant Neoplasm in the Bone Metastatic Malignant Neoplasm in the Bone Marrow Metastatic Malignant Neoplasm in the Lung Metastatic Peripheral Primitive Neuroectodermal Tumor of Bone Peripheral Primitive Neuroectodermal Tumor of Soft Tissues Drug: Cyclophosphamide Drug: Doxorubicin Hydrochloride Drug: Etoposide Radiation: External Beam Radiation Therapy Biological: Ganitumab Drug: Ifosfamide Other: Laboratory Biomarker Analysis Other: Pharmacological Study Radiation: Stereotactic Radiosurgery Procedure: Therapeutic Surgical Procedure Drug: Vincristine Sulfate Phase 3

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Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if the event-free survival (EFS) in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy is improved with the addition of ganitumab (AMG 479).

SECONDARY OBJECTIVES:

I. To describe the toxicity of the addition of ganitumab to multimodality therapy for patients with newly diagnosed metastatic Ewing sarcoma.

II. To compare overall survival in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab.

TERTIARY OBJECTIVES:

I. To compare bone marrow response rates in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab.

II. To describe the toxicity of 6 months of ganitumab monotherapy as maintenance therapy following multimodality therapy in patients with newly diagnosed metastatic Ewing sarcoma.

III. To describe trough levels of ganitumab in a cohort of patients with Ewing sarcoma < 21 years of age treated with 18 mg/kg.

IV. To describe the feasibility of and local failure rates following hypofractionated stereotactic body radiotherapy (SBRT) directed at bone metastases in patients with newly diagnosed metastatic Ewing sarcoma.

V. To determine if EFS, overall survival, bone marrow response rates, and toxicity differ based on serum markers of the insulin-like growth factor 1 (IGF-1) pathway in patients with newly diagnosed metastatic Ewing sarcoma treated with interval compressed chemotherapy with and without the addition of ganitumab.

VI. To determine if EFS, overall survival, and bone marrow response rates differ based on protein, deoxyribose nucleic acid (DNA), and ribonucleic acid (RNA) marker in patients with newly diagnosed metastatic Ewing sarcoma treated with interval compressed chemotherapy with and without the addition of ganitumab.

VII. To evaluate bone marrow micrometastatic disease and tumor cell surface IGF-1R expression at diagnosis and after 3 and 6 cycles of study therapy in patients with newly diagnosed metastatic Ewing sarcoma.

VIII. To determine if the presence of germline polymorphisms in EGFR correlate with response to multiagent therapy with and without ganitumab.

IX. To investigate the ability of fludeoxyglucose F 18-positron emission tomography (FDG-PET) to augment conventional response assessment of primary Ewing sarcoma tumors by magnetic resonance imaging (MRI).

X. To explore FDG-PET response at the primary tumor as a prognostic marker and as a predictive biomarker of clinical activity of IGF-1R inhibition in patients with newly diagnosed metastatic Ewing sarcoma.

XI. To collect data on institutional testing for Ewing sarcoma breakpoint region 1 (EWSR1) translocation status in patients enrolling on study.

XII. To explore the capacity of plasma cell-free DNA analysis to detect tumor-specific genetic changes at initial diagnosis and after initiation of protocol therapy.

XIII. To collect a population of bone marrow metastatic tumor cells by flow cytometry for genomic profiling.

OUTLINE: Patients are randomized to 1 of 2 treatment regimens.

REGIMEN A (vincristine sulfate, doxorubicin hydrochloride and cyclophosphamide [VDC] and ifosfamide and etoposide [IE]):

INDUCTION THERAPY: Patients receive vincristine sulfate intravenously (IV) over 1 minute on day 1; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2; and cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 5, and 9; and ifosfamide IV over 1 hour on days 1 to 5 and etoposide IV over 1-2 hours on days 1 to 5 of weeks 3, 7, and 11.

LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.

CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1, 7, 9, and 13; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 1 and 7; cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 7, 9, and 13; ifosfamide IV over 1 hour on days 1 to 5 of weeks 3, 5, 11, and 15; and etoposide IV over 1-2 hours on days 1 to 5 of weeks 3, 5, 11, and 15.

METASTATIC SITE IRRADIATION: Patients with lung metastases undergo definitive SBRT or external beam radiation therapy (EBRT) over 5 days.

REGIMEN B (VDC/IE + ganitumab):

INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11.

LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.

CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15.

METASTATIC SITE IRRADIATION: Patients with lung metastases undergo definitive SBRT or EBRT over 5 days.

MAINTENANCE THERAPY: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 in weeks 1, 4, 7, 10, 13, 16, 19, and 22.

After completion of study treatment, patients are followed for 10 years.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase 3 Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008) to Multiagent Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma
Actual Study Start Date : December 8, 2014
Estimated Primary Completion Date : December 31, 2018


Arm Intervention/treatment
Experimental: Regimen A (VDC/IE)

INDUCTION THERAPY: Patients receive vincristine sulfate IV over 1 minute on day 1; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2; and cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 5, and 9; and ifosfamide IV over 1 hour on days 1 to 5 and etoposide IV over 1-2 hours on days 1 to 5 of weeks 3, 7, and 11.

LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.

CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1, 7, 9, and 13; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 1 and 7; cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 7, 9, and 13; ifosfamide IV over 1 hour on days 1 to 5 of weeks 3, 5, 11, and 15; and etoposide IV over 1-2 hours on days 1 to 5 of weeks 3, 5, 11, and 15.

METASTATIC SITE IRRADIATION: Patients with lung metastases undergo definitive SBRT or EBRT over 5 days.

Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719

Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16-213
  • VP-16
  • VP-16-213

Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation

Drug: Ifosfamide
Given IV
Other Names:
  • Asta Z 4942
  • Asta Z-4942
  • Cyfos
  • Holoxan
  • Holoxane
  • Ifex
  • IFO
  • IFO-Cell
  • Ifolem
  • Ifomida
  • Ifomide
  • Ifosfamidum
  • Ifoxan
  • IFX
  • Iphosphamid
  • Iphosphamide
  • Iso-Endoxan
  • Isoendoxan
  • Isophosphamide
  • Mitoxana
  • MJF 9325
  • MJF-9325
  • Naxamide
  • Seromida
  • Tronoxal
  • Z 4942
  • Z-4942

Other: Laboratory Biomarker Analysis
Correlative studies

Radiation: Stereotactic Radiosurgery
Undergo SBRT
Other Names:
  • Stereotactic External Beam Irradiation
  • stereotactic external-beam radiation therapy
  • stereotactic radiation therapy
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery

Procedure: Therapeutic Surgical Procedure
Undergo surgery

Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate

Experimental: Regimen B (VDC/IE + ganitumab)

INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11.

LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.

CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15.

METASTATIC SITE IRRADIATION: Patients with lung metastases undergo definitive SBRT or EBRT over 5 days.

MAINTENANCE THERAPY: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 in weeks 1, 4, 7, 10, 13, 16, 19, and 22.

Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719

Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16-213
  • VP-16
  • VP-16-213

Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation

Biological: Ganitumab
Given IV
Other Names:
  • AMG 479
  • Anti-IGF-1R Human Monoclonal Antibody AMG-479

Drug: Ifosfamide
Given IV
Other Names:
  • Asta Z 4942
  • Asta Z-4942
  • Cyfos
  • Holoxan
  • Holoxane
  • Ifex
  • IFO
  • IFO-Cell
  • Ifolem
  • Ifomida
  • Ifomide
  • Ifosfamidum
  • Ifoxan
  • IFX
  • Iphosphamid
  • Iphosphamide
  • Iso-Endoxan
  • Isoendoxan
  • Isophosphamide
  • Mitoxana
  • MJF 9325
  • MJF-9325
  • Naxamide
  • Seromida
  • Tronoxal
  • Z 4942
  • Z-4942

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacological Study
Correlative studies

Radiation: Stereotactic Radiosurgery
Undergo SBRT
Other Names:
  • Stereotactic External Beam Irradiation
  • stereotactic external-beam radiation therapy
  • stereotactic radiation therapy
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery

Procedure: Therapeutic Surgical Procedure
Undergo surgery

Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate




Primary Outcome Measures :
  1. Time to adverse analytic event (event-free survival [EFS]), defined to be disease-related event, diagnosis of a second malignant neoplasm, or death [ Time Frame: From the time of randomization, assessed up to 10 years ]
    The two regimens will be compared using the relative risk regression model with strata representing those used for randomization. A log-partial-likelihood one-sided test of size 0.20 will be used to compare the two regimens. A parametric model that treats disease progressions identified at routine visits as interval censored observations with the left censoring time as the date of the last screening prior to the identification of the relapse and other relapse times as being known exactly will be fit.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From enrollment to death regardless of cause or last patient contact, assessed up to 10 years ]
  2. Overall toxicity of the addition of ganitumab to vincristine sulfate, doxorubicin hydrochloride and cyclophosphamide (VDC)/ifosfamide and etoposide (IE), using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days after last dose of study drug ]
    The 95% confidence interval for the toxicity-event rate for each phase noted above for patients enrolled on the comparator therapy will be constructed.

  3. Sinusoidal obstructive disease (SOS) associated with the addition of ganitumab to VDC/IE [ Time Frame: Up to 30 days after last dose of study drug ]
    A phase where a patient experiences any SOS will be considered a phase with an SOS toxicity-event. The effect of possible correlations between analytic units that arises because some analytic units are contributed by the same individual will be explored. A random effects binomial model where a Normally distributed random effect with 0 mean and unknown variance chi-squared is contributed by each unit in a pair of analytic units that arise from the same individual will be explored.

  4. Risk of death [ Time Frame: Up to 10 years ]
    The relative risk for death and the naïve p-value associated with the null hypothesis H0: relative risk for death is 1 will be estimated using the stratified partial likelihood for the relative risk regression model accounting for the factors used to stratify randomization at the time full information is obtained for the EFS comparison.

  5. Bone marrow response rates [ Time Frame: Up to 10 years ]
    Each bone marrow evaluable patient will be assessed for the presence or absence of bone marrow metastatic disease over the interval between enrollment and the time of first local control measure or the end of the Induction reporting period, whichever comes first. Only one evaluation of best response will be used to classify the patient as complete responder (no evidence of marrow disease) or incomplete responder (residual marrow disease or progression). An estimate of the proportion of patients who achieve complete bone marrow response and an associated 95% confidence interval provided.

  6. Tolerability of maintenance ganitumab [ Time Frame: Up to 10 years ]
    At the time each study progress report is prepared, the toxicity-event rate will be calculated and the one-sided test of size 0.05 of the null hypothesis that the toxicity-event rate is 25% will be performed.

  7. Ganitumab pharmacokinetics (PK) [ Time Frame: Pre-dose, prior to the second dose of ganitumab on Induction day 15, prior to the third dose of ganitumab on Induction day 29, prior to the sixth dose of ganitumab on Induction day 71 (Induction), and weeks 1, 7, 10, and 16 (maintenance) ]
    Results of this PK testing will be reported descriptively, with an emphasis on the proportion of patients achieving a trough serum ganitumab concentration >= 10 µg/mL at a dose of 18 mg/kg IV every 3 weeks. Additional trough levels in Maintenance will allow for estimation of accumulation, half-life, and steady state clearance of ganitumab.

  8. Feasibility of stereotactic body radiotherapy (SBRT) [ Time Frame: Up to 10 years ]
    Defined as an individual that has SBRT planned for at least one site, starts the treatment of metastatic disease phase of the protocol and has at least 85% of tumor sites planned to be treated with SBRT receive successful SBRT. Successful treatment delivery is defined as a treatment plan that is acceptable or has only minor variation as assessed by Imaging and Radiation Oncology Core (IROC) Rhode Island (formerly Quality Assurance Review Center [QARC]). In addition to this feasibility assessment, efficacy will be evaluated by comparing the failure rate at irradiated bone metastases with SBRT and EBRT, recognizing selection bias between patients treated with SBRT or EBRT.


Other Outcome Measures:
  1. Serum IGF pathway component and tissue protein, deoxyribonucleic acid (DNA), and ribonucleic acid (RNA) markers [ Time Frame: Up to 10 years ]
    In addition to the log rank test the modeling approach will be used for the primary study comparison. Linear trend in EFS-risk will be investigated by segregating the marker level according to quartiles. For bone marrow response rate analyses, Fisher's exact test will be used to compare the objective bone marrow response rate (complete response vs. incomplete response) at start of local control between patients with biomarker levels above and below the group median.

  2. Tumor cell surface IGF-1R expression [ Time Frame: Up to 10 years ]
    The percentage of patients with detectable bone marrow micrometastatic disease at baseline who clear their bone marrow micrometastatic disease after three and six cycles of study therapy will be reported descriptively according to treatment arm. Extent of tumor cell IGF-1R co-expression will also be reported. Moreover, the change in tumor cell IGF-1R co-expression in patients treated with and without ganitumab will be reported descriptively.

  3. Germline polymorphisms in EGFR [ Time Frame: Up to 10 years ]
    EFS will be compared between patients with and without the presence of the minor allele using the log rank test, both for the entire patient population and for patients randomized to ganitumab. In addition to the log rank test we will use the modeling approach described above for the primary study comparison. Additional analyses will compare overall survival and objective bone marrow response rate prior to local control as clinical outcomes of interest. In addition, an association between the number of copies of the minor allele and these clinical endpoints will be evaluated.

  4. EWS translocation [ Time Frame: Up to 10 years ]
    The institutional result of EWS tumor testing will be categorized as translocation detected (yes v. no) and the type of translocation detected will also be recorded. The proportion of patients with a particular EWS translocation variant will be tabulated. Risk for EFS-event will be compared across groups defined by translocation positivity using the log rank test.

  5. Circulating tumor DNA (ctDNA) testing [ Time Frame: Up to 10 years ]
    Will report the proportion of patients that have a change in translocation result associated with ctDNA testing across time periods.

  6. Serial genomic profiling identified by flow cytometry [ Time Frame: Up to 10 years ]
    Profiles will be presented graphically, and samples obtained from different sites of tumor within the same individual will also be presented.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone or soft tissue and with metastatic disease involving lung, bone, bone marrow, or other metastatic site
  • For the purpose of this study metastatic disease is defined as one or more of the following:

    • Lesions which are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a bone or body cavity with the primary tumor; skip lesions in the same bone as the primary tumor do not constitute metastatic disease; skip lesions in an adjacent bone are considered bone metastases; if there is any doubt whether lesions are metastatic, a biopsy of those lesions should be performed
    • Contralateral pleural effusion and/or contralateral pleural nodules
    • Distant lymph node involvement
    • Patients with pulmonary nodules are considered to have metastatic disease if the patient has:

      • Solitary nodule >= 0.5 cm or multiple nodules of >= 0.3 cm unless lesion is biopsied and negative for tumor
      • Patients with solitary nodule < 0.5 cm or multiple nodules < 0.3 cm are not considered to have lung metastasis unless biopsy documents tumor
    • Bone marrow metastatic disease is based on morphologic evidence of Ewing sarcoma based on hematoxylin and eosin (H&E) stains; in the absence of morphologic evidence of marrow involvement on H&E, patients with bone marrow involvement detected ONLY by flow cytometry, reverse-transcriptase (RT)-polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study

      • This study requires bilateral bone marrow biopsies at study entry; the suggested approach for patients with large pelvic tumors in which a posterior iliac crest bone marrow biopsy would track through the tumor is to instead undergo 2 marrow biopsies on the contralateral side (either 2 posterior biopsies or one posterior and one anterior biopsy)
    • Bone metastasis: This study utilizes whole body FDG-PET scans to screen patients for bone metastases; areas suspicious for bone metastasis based on FDG-PET scans require confirmatory anatomic imaging with either MRI or computed tomography (CT) (whole body FDG-PET/CT or FDG-PET/magnetic resonance [MR] scan acceptable); whole body technetium bone scans may be performed at the discretion of the investigator and are not required; for patients without other sites of metastatic disease whose sole metastatic site to qualify for study entry is a single area suspicious for bone metastasis identified by FDG-PET, confirmatory biopsy or anatomic imaging evidence of an associated soft tissue mass at that site is required for study entry
  • Patients must have adequate tumor tissue to meet the minimum requirement for submission
  • Enrolling institutions are reminded that submission of pre-treatment serum, tumor tissue and whole blood is required
  • Patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection; patients will still be eligible if excision was attempted or accomplished as long as adequate anatomic imaging (MRI for most primary tumor sites) was obtained prior to surgery
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

    • Age < 6 months: Maximum serum creatinine (mg/dL): 0.4 for males and females
    • Age 6 months to < 1 year: Maximum serum creatinine (mg/dL): 0.5 for males and females
    • Age 1 to < 2 years: Maximum serum creatinine (mg/dL): 0.6 for males and females
    • Age 2 to < 6 years: Maximum serum creatinine (mg/dL): 0.8 for males and females
    • Age 6 to < 10 years: Maximum serum creatinine (mg/dL): 1 for males and females
    • Age 10 to < 13 years: Maximum serum creatinine (mg/dL): 1.2 for males and females
    • Age 13 to < 16 years: Maximum serum creatinine (mg/dL): 1.5 for males and 1.4 for females
    • Age >= 16 years: Maximum serum creatinine (mg/dL): 1.7 for males and 1.4 for females
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x upper limit of normal (ULN) for age (except for patients with liver metastasis who may enroll if ALT < 5 times ULN for age)
  • Shortening fraction of >= 27% or
  • Ejection fraction of >= 50%
  • Patients must have a normal blood sugar level for age to participate; if an initial random draw (ie. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting draw
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

  • Patients with regional node involvement as their only site of disease beyond the primary tumor will not be eligible
  • Patients whose primary tumors arise in the intra-dural soft tissue (eg. brain and spinal cord) are not eligible
  • Patients who have received prior chemotherapy or radiation therapy are not eligible
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained; lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of protocol therapy; sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of protocol therapy
  • Patients with known pre-existing diabetes mellitus will be excluded from study
  • Patients receiving chronic pharmacologic doses of corticosteroids are not eligible; for the purposes of eligibility, chronic exposure is defined as anticipated exposure of > 3 weeks, including the sum of both pre-enrollment and anticipated post-enrollment dosing; patients on acute corticosteroid therapy (=< 3 weeks of total planned exposure) must still meet the normal blood glucose requirement; patients receiving chronic inhaled corticosteroids or chronic physiologic replacement doses of corticosteroids are eligible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306161


  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Matthew A. Kutny         
University of South Alabama Suspended
Mobile, Alabama, United States, 36604
United States, Alaska
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Brenda J. Wittman         
United States, Arizona
Cardon Children's Medical Center Recruiting
Mesa, Arizona, United States, 85202
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Erlyn C. Smith         
Phoenix Childrens Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Site Public Contact    602-546-0920      
Principal Investigator: Jessica Boklan         
The University of Arizona Medical Center-University Campus Recruiting
Tucson, Arizona, United States, 85724
Contact: Site Public Contact    520-626-9008      
Principal Investigator: Lisa M. Kopp         
Yuma Cancer Center Recruiting
Yuma, Arizona, United States, 85364
Contact: Site Public Contact    928-336-3366      
Principal Investigator: Lisa M. Kopp         
United States, Arkansas
CHI Saint Vincent Cancer Center Hot Springs Recruiting
Hot Springs, Arkansas, United States, 71913
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: David L. Becton         
United States, California
Kaiser Permanente Downey Medical Center Recruiting
Downey, California, United States, 90242
Contact: Site Public Contact    626-564-3455      
Principal Investigator: Robert M. Cooper         
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Site Public Contact    800-826-4673    becomingapatient@coh.org   
Principal Investigator: Anna B. Pawlowska         
Loma Linda University Medical Center Suspended
Loma Linda, California, United States, 92354
Miller Children's and Women's Hospital Long Beach Suspended
Long Beach, California, United States, 90806
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Leo Mascarenhas         
Children's Hospital Central California Recruiting
Madera, California, United States, 93636-8762
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Vonda L. Crouse         
Children's Hospital and Research Center at Oakland Recruiting
Oakland, California, United States, 94609-1809
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Carla B. Golden         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Steven K. Bergstrom         
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Elyssa M. Rubin         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Sheri L. Spunt         
Sutter Medical Center Sacramento Recruiting
Sacramento, California, United States, 95816
Contact: Site Public Contact    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Yung S. Yim         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Site Public Contact    916-734-3089      
Principal Investigator: Marcio H. Malogolowkin         
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: William D. Roberts         
UCSF Medical Center-Parnassus Active, not recruiting
San Francisco, California, United States, 94143
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Site Public Contact    877-827-3222      
Principal Investigator: Robert E. Goldsby         
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Site Public Contact    310-222-3621      
Principal Investigator: Eduard H. Panosyan         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Timothy P. Garrington         
Penrose-Saint Francis Healthcare Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Rocky Mountain Cancer Centers-Penrose Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jennifer J. Clark         
Mercy Medical Center Suspended
Durango, Colorado, United States, 81301
Southwest Oncology PC Recruiting
Durango, Colorado, United States, 81301
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Mountain Blue Cancer Care Center Recruiting
Golden, Colorado, United States, 80401
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Rocky Mountain Cancer Centers-Lakewood Recruiting
Lakewood, Colorado, United States, 80228
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Saint Anthony Hospital Recruiting
Lakewood, Colorado, United States, 80228
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Littleton Adventist Hospital Recruiting
Littleton, Colorado, United States, 80122
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Longmont United Hospital Recruiting
Longmont, Colorado, United States, 80501
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Rocky Mountain Cancer Centers-Longmont Recruiting
Longmont, Colorado, United States, 80501
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Parker Adventist Hospital Recruiting
Parker, Colorado, United States, 80138
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Rocky Mountain Cancer Centers-Parker Recruiting
Parker, Colorado, United States, 80138
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Saint Mary Corwin Medical Center Recruiting
Pueblo, Colorado, United States, 81004
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Rocky Mountain Cancer Centers - Pueblo Recruiting
Pueblo, Colorado, United States, 81008
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Rocky Mountain Cancer Centers-Thornton Recruiting
Thornton, Colorado, United States, 80260
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Michael S. Isakoff         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Site Public Contact    203-785-5702    canceranswers@yale.edu   
Principal Investigator: Nina S. Kadan-Lottick         
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Site Public Contact    302-651-6884    dperry@nemours.org   
Principal Investigator: Scott M. Bradfield         
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Site Public Contact    202-444-2223      
Principal Investigator: Corina E. Gonzalez         
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jeffrey S. Dome         
United States, Florida
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Emad K. Salman         
University of Florida Health Science Center - Gainesville Suspended
Gainesville, Florida, United States, 32610
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Iftikhar Hanif         
Nemours Children's Clinic-Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Site Public Contact    305-243-2647      
Principal Investigator: Julio C. Barredo         
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Enrique A. Escalon         
Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Site Public Contact    407-303-2090    FH.Cancer.Research@flhosp.org   
Principal Investigator: Fouad M. Hajjar         
Arnold Palmer Hospital for Children Recruiting
Orlando, Florida, United States, 32806
Contact: Site Public Contact    321-843-2584    melissa.leffin@orlandohealth.com   
Principal Investigator: Vincent F. Giusti         
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
Nemours Children's Clinic - Pensacola Active, not recruiting
Pensacola, Florida, United States, 32504
Johns Hopkins All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jonathan L. Metts         
Saint Joseph's Hospital/Children's Hospital-Tampa Suspended
Tampa, Florida, United States, 33607
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: William T. Cash         
Augusta University Medical Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Site Public Contact    706-721-2388    ga_cares@augusta.edu   
Principal Investigator: Colleen H. McDonough         
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: Site Public Contact    912-350-7887    clayter1@memorialhealth.com   
Principal Investigator: J. M. Johnston         
United States, Hawaii
Straub Clinic and Hospital Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-522-4333      
Principal Investigator: Wade T. Kyono         
Kaiser Permanente Moanalua Medical Center Recruiting
Honolulu, Hawaii, United States, 96819
Contact: Site Public Contact    808-432-5195    shelley.a.clark@kp.org   
Principal Investigator: Wade T. Kyono         
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Site Public Contact    808-983-6090      
Principal Investigator: Wade T. Kyono         
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eugenia Chang         
United States, Illinois
Rush - Copley Medical Center Recruiting
Aurora, Illinois, United States, 60504
Contact: Site Public Contact    630-978-6212    Cancer.Research@rushcopley.com   
Principal Investigator: Yujie Zhao         
Lurie Children's Hospital-Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: David O. Walterhouse         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Site Public Contact    312-355-3046      
Principal Investigator: Mary L. Schmidt         
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Site Public Contact    773-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
Principal Investigator: Susan L. Cohn         
Carle on Vermilion Recruiting
Danville, Illinois, United States, 61832
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Yujie Zhao         
Carle Physician Group-Effingham Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Yujie Zhao         
Carle Physician Group-Mattoon/Charleston Recruiting
Mattoon, Illinois, United States, 61938
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Yujie Zhao         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Site Public Contact    708-226-4357      
Principal Investigator: Eugene Suh         
Good Samaritan Regional Health Center Recruiting
Mount Vernon, Illinois, United States, 62864
Contact: Site Public Contact    618-242-4600      
Principal Investigator: Jay W. Carlson         
Advocate Children's Hospital-Oak Lawn Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Rebecca E. McFall         
Advocate Children's Hospital-Park Ridge Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Caroline Y. Hu         
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Site Public Contact    888-226-4343      
Principal Investigator: Pedro A. De Alarcon         
Saint John's Hospital Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Gregory P. Brandt         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    217-545-7929      
Principal Investigator: Gregory P. Brandt         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Contact: Site Public Contact    217-788-3528      
Principal Investigator: Gregory P. Brandt         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Yujie Zhao         
The Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Yujie Zhao         
Rush-Copley Healthcare Center Recruiting
Yorkville, Illinois, United States, 60560
Contact: Site Public Contact    630-978-6212    Cancer.Research@rushcopley.com   
Principal Investigator: Yujie Zhao         
United States, Indiana
Deaconess Clinic Downtown Recruiting
Evansville, Indiana, United States, 47713
Contact: Site Public Contact    877-654-0311    Research@Deaconess.com   
Principal Investigator: Yujie Zhao         
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    800-248-1199      
Principal Investigator: Kamnesh R. Pradhan         
Saint Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Site Public Contact    317-338-2194    research@stvincent.org   
Principal Investigator: Bassem I. Razzouk         
Franciscan Saint Anthony Health-Michigan City Suspended
Michigan City, Indiana, United States, 46360
Woodland Cancer Care Center Suspended
Michigan City, Indiana, United States, 46360
Chancellor Center for Oncology Recruiting
Newburgh, Indiana, United States, 47630
Contact: Site Public Contact    877-654-0311    Research@Deaconess.com   
Principal Investigator: Yujie Zhao         
United States, Iowa
Medical Oncology and Hematology Associates-West Des Moines Recruiting
Clive, Iowa, United States, 50325
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Mercy Cancer Center-West Lakes Recruiting
Clive, Iowa, United States, 50325
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Alegent Health Mercy Hospital Recruiting
Council Bluffs, Iowa, United States, 51503
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Greater Regional Medical Center Recruiting
Creston, Iowa, United States, 50801
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Wendy L. Woods-Swafford         
Medical Oncology and Hematology Associates-Laurel Recruiting
Des Moines, Iowa, United States, 50314
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
University of Iowa/Holden Comprehensive Cancer Center Suspended
Iowa City, Iowa, United States, 52242
Mercy Medical Center-West Lakes Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
United States, Kentucky
Flaget Memorial Hospital Recruiting
Bardstown, Kentucky, United States, 40004
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Commonwealth Cancer Center-Corbin Recruiting
Corbin, Kentucky, United States, 40701
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Saint Joseph Radiation Oncology Resource Center Recruiting
Lexington, Kentucky, United States, 40504
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Saint Joseph Hospital East Recruiting
Lexington, Kentucky, United States, 40509
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Site Public Contact    859-257-3379      
Principal Investigator: Vlad C. Radulescu         
Saint Joseph London Recruiting
London, Kentucky, United States, 40741
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Jewish Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Norton Children's Hospital Suspended
Louisville, Kentucky, United States, 40202
Saints Mary and Elizabeth Hospital Recruiting
Louisville, Kentucky, United States, 40215
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Jewish Hospital Medical Center Northeast Recruiting
Louisville, Kentucky, United States, 40245
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Jewish Hospital Medical Center South Recruiting
Shepherdsville, Kentucky, United States, 40165
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
United States, Louisiana
Children's Hospital New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Lolie C. Yu         
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Site Public Contact    504-703-8712    Gregory.Johnstone@ochsner.org   
Principal Investigator: Craig Lotterman         
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Site Public Contact    207-973-4274      
Principal Investigator: Nadine P. SantaCruz         
Maine Children's Cancer Program Recruiting
Scarborough, Maine, United States, 04074
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Aaron R. Weiss         
United States, Maryland
University of Maryland/Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Site Public Contact    800-888-8823      
Principal Investigator: Teresa A. York         
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Site Public Contact    410-601-6120    pridgely@lifebridgehealth.org   
Principal Investigator: Jason M. Fixler         
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Site Public Contact    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Nicolas J. Llosa         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Site Public Contact    301-319-2100      
Principal Investigator: Kenneth Lieuw         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Site Public Contact    877-726-5130      
Principal Investigator: Steven G. DuBois         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Site Public Contact    877-442-3324      
Principal Investigator: Steven G. DuBois         
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Site Public Contact    413-794-3565    tamara.wrenn@baystatehealth.org   
Principal Investigator: Joanna G. Luty         
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Site Public Contact    508-856-3216    cancer.research@umassmed.edu   
Principal Investigator: Christopher P. Keuker         
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Rama Jasty         
Bronson Battle Creek Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Roland L. Chu         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Adonis N. Lorenzana         
Hurley Medical Center Active, not recruiting
Flint, Michigan, United States, 48503
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Kathleen J. Yost         
Mercy Health Saint Mary's Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Kathleen J. Yost         
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49048
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Mercy Health Mercy Campus Recruiting
Muskegon, Michigan, United States, 49444
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Lakeland Hospital Niles Recruiting
Niles, Michigan, United States, 49120
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Kathleen J. Yost         
Huron Medical Center PC Recruiting
Port Huron, Michigan, United States, 48060
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Lake Huron Medical Center Recruiting
Port Huron, Michigan, United States, 48060
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Spectrum Health Reed City Hospital Recruiting
Reed City, Michigan, United States, 49677
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Beaumont Children's Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Site Public Contact    248-551-0360      
Principal Investigator: Laura K. Gowans         
Lakeland Medical Center Saint Joseph Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Marie Yeager Cancer Center Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
United States, Minnesota
Essentia Health Cancer Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Site Public Contact    218-786-3308    CancerTrials@EssentiaHealth.org   
Principal Investigator: Emily G. Greengard         
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Michael K. Richards         
University of Minnesota/Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Emily G. Greengard         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Site Public Contact    855-776-0015      
Principal Investigator: Nadia N. Laack         
United States, Mississippi
University of Mississippi Medical Center Suspended
Jackson, Mississippi, United States, 39216
United States, Missouri
Central Care Cancer Center - Bolivar Suspended
Bolivar, Missouri, United States, 65613
Cox Cancer Center Branson Recruiting
Branson, Missouri, United States, 65616
Contact: Site Public Contact    417-269-4520      
Principal Investigator: Jay W. Carlson         
Columbia Regional Active, not recruiting
Columbia, Missouri, United States, 65201
Freeman Health System Recruiting
Joplin, Missouri, United States, 64804
Contact: Site Public Contact    417-347-4030    LJCrockett@freemanhealth.com   
Principal Investigator: Jay W. Carlson         
Mercy Hospital Joplin Recruiting
Joplin, Missouri, United States, 64804
Contact: Site Public Contact    417-556-3074    esmeralda.carrillo@mercy.net   
Principal Investigator: Jay W. Carlson         
The Childrens Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Keith J. August         
Delbert Day Cancer Institute at PCRMC Recruiting
Rolla, Missouri, United States, 65401
Contact: Site Public Contact    573-458-7504    jrichards@research.pcrmc.com   
Principal Investigator: Jay W. Carlson         
Mercy Clinic-Rolla-Cancer and Hematology Recruiting
Rolla, Missouri, United States, 65401
Contact: Site Public Contact    573-458-7504    jrichards@research.pcrmc.com   
Principal Investigator: Jay W. Carlson         
Heartland Regional Medical Center Recruiting
Saint Joseph, Missouri, United States, 64507
Contact: Site Public Contact    816-271-7937    linda.schumacher@mymlc.com   
Principal Investigator: Jay W. Carlson         
Cardinal Glennon Children's Medical Center Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: William S. Ferguson         
Saint Louis Cancer and Breast Institute-South City Recruiting
Saint Louis, Missouri, United States, 63109
Contact: Site Public Contact    314-353-1870      
Principal Investigator: Jay W. Carlson         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Frederick S. Huang         
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Site Public Contact    314-251-6770      
Principal Investigator: Jay W. Carlson         
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Site Public Contact    417-269-4520      
Principal Investigator: Jay W. Carlson         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Site Public Contact    417-269-4520      
Principal Investigator: Jay W. Carlson         
United States, Nebraska
Nebraska Medicine-Bellevue Recruiting
Bellevue, Nebraska, United States, 68123
Contact: Site Public Contact    402-559-6941    unmcrsa@unmc.edu   
Principal Investigator: Minnie Abromowitch         
CHI Health Saint Francis Recruiting
Grand Island, Nebraska, United States, 68803
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Heartland Hematology and Oncology Recruiting
Kearney, Nebraska, United States, 68845
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
CHI Health Good Samaritan Recruiting
Kearney, Nebraska, United States, 68847
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Saint Elizabeth Regional Medical Center Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Minnie Abromowitch         
Nebraska Medicine-Village Pointe Recruiting
Omaha, Nebraska, United States, 68118
Contact: Site Public Contact    402-559-5600      
Principal Investigator: Minnie Abromowitch         
Alegent Health Immanuel Medical Center Recruiting
Omaha, Nebraska, United States, 68122
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Hematology and Oncology Consultants PC Recruiting
Omaha, Nebraska, United States, 68122
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Alegent Health Bergan Mercy Medical Center Recruiting
Omaha, Nebraska, United States, 68124
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Alegent Health Lakeside Hospital Recruiting
Omaha, Nebraska, United States, 68130
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Creighton University Medical Center Recruiting
Omaha, Nebraska, United States, 68131
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Site Public Contact    402-559-6941    unmcrsa@unmc.edu   
Principal Investigator: Minnie Abromowitch         
Midlands Community Hospital Recruiting
Papillion, Nebraska, United States, 68046
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
United States, Nevada
Carson Tahoe Regional Medical Center Recruiting
Carson City, Nevada, United States, 89703
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Comprehensive Cancer Centers of Nevada-Horizon Ridge Recruiting
Henderson, Nevada, United States, 89052
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Nik F. Nik Abdul Rashid    702-384-0013      
Principal Investigator: Nik F. Nik Abdul Rashid         
Children's Specialty Center of Nevada II Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Alan K. Ikeda         
Sunrise Hospital and Medical Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Ann M Wierman MD LTD Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Summerlin Hospital Medical Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Hope Cancer Care of Nevada-Pahrump Recruiting
Pahrump, Nevada, United States, 89048
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Saint Mary's Regional Medical Center Recruiting
Reno, Nevada, United States, 89503
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Alan K. Ikeda         
Radiation Oncology Associates Recruiting
Reno, Nevada, United States, 89509
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Site Public Contact    800-639-6918    cancer.research.nurse@dartmouth.edu   
Principal Investigator: Sara Chaffee         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Site Public Contact    201-996-2879      
Principal Investigator: Katharine Offer         
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Site Public Contact    973-971-5900      
Principal Investigator: Steven L. Halpern         
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nibal A. Zaghloul         
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Site Public Contact    732-235-8675      
Principal Investigator: Richard A. Drachtman         
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Site Public Contact    973-926-7230      
Principal Investigator: Peri Kamalakar         
Saint Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mary A. Bonilla         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Site Public Contact    518-262-5513      
Principal Investigator: Kenneth G. Lucas         
Montefiore Medical Center-Einstein Campus Recruiting
Bronx, New York, United States, 10461
Contact: Site Public Contact    718-379-6866    aaraiza@montefiore.org   
Principal Investigator: Lisa Gennarini         
Montefiore Medical Center-Weiler Hospital Recruiting
Bronx, New York, United States, 10461
Contact: Site Public Contact    718-379-6866    aaraiza@montefiore.org   
Principal Investigator: Lisa Gennarini         
Children's Hospital at Montefiore Recruiting
Bronx, New York, United States, 10467
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Lisa Gennarini         
Montefiore Medical Center - Moses Campus Recruiting
Bronx, New York, United States, 10467
Contact: Site Public Contact    718-379-6866    aaraiza@montefiore.org   
Principal Investigator: Lisa Gennarini         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Site Public Contact    800-767-9355    askroswell@roswellpark.org   
Principal Investigator: Clare J. Twist         
Glens Falls Hospital Recruiting
Glens Falls, New York, United States, 12801
Contact: Site Public Contact    518-926-6700      
Principal Investigator: Jessica L. Heath         
NYU Winthrop Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Site Public Contact    516-663-3115      
Principal Investigator: Mark E. Weinblatt         
The Steven and Alexandra Cohen Children's Medical Center of New York Recruiting
New Hyde Park, New York, United States, 11040
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Arlene S. Redner         
Laura and Isaac Perlmutter Cancer Center at NYU Langone Suspended
New York, New York, United States, 10016
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Site Public Contact    212-824-7309    CCTO@mssm.edu   
Principal Investigator: Birte Wistinghausen         
Columbia University/Herbert Irving Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Site Public Contact    212-305-6361    nr2616@cumc.columbia.edu   
Principal Investigator: Alice Lee         
University of Rochester Suspended
Rochester, New York, United States, 14642
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Site Public Contact    800-862-2215      
Principal Investigator: Laura E. Hogan         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Site Public Contact    315-464-5476      
Principal Investigator: Philip M. Monteleone         
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Site Public Contact    914-594-3794      
Principal Investigator: Jessica C. Hochberg         
United States, North Carolina
Mission Hospital Inc-Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Site Public Contact    828-213-4150    leslie.verner@msj.org   
Principal Investigator: Douglas J. Scothorn         
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Site Public Contact    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Stuart H. Gold         
Carolinas Medical Center/Levine Cancer Institute Suspended
Charlotte, North Carolina, United States, 28203
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Site Public Contact    888-275-3853      
Principal Investigator: Susan G. Kreissman         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Site Public Contact    336-713-6771      
Principal Investigator: Thomas B. Russell         
United States, North Dakota
Sanford Broadway Medical Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Site Public Contact    800-437-4010      
Principal Investigator: Samuel O. Anim         
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Steven J. Kuerbitz         
Good Samaritan Hospital - Cincinnati Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Cincinnati Children's Hospital Medical Center Suspended
Cincinnati, Ohio, United States, 45229
Bethesda North Hospital Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
TriHealth Cancer Institute-Westside Recruiting
Cincinnati, Ohio, United States, 45247
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
TriHealth Cancer Institute-Anderson Recruiting
Cincinnati, Ohio, United States, 45255
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Site Public Contact    216-844-5437      
Principal Investigator: John J. Letterio         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Aron Flagg         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mark A. Ranalli         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Ayman A. El-Sheikh         
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Site Public Contact    419-824-1842      
Principal Investigator: Jamie L. Dargart         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Rene Y. McNall-Knapp         
Mercy Hospital Oklahoma City Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Site Public Contact    405-752-3402      
Principal Investigator: Jay W. Carlson         
United States, Oregon
Legacy Emanuel Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Janice F. Olson         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Site Public Contact    503-494-1080    trials@ohsu.edu   
Principal Investigator: Linda C. Stork         
United States, Pennsylvania
Lehigh Valley Hospital-Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Lydia A. Boateng         
Lehigh Valley Hospital - Muhlenberg Active, not recruiting
Bethlehem, Pennsylvania, United States, 18017
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Site Public Contact    570-271-5251    HemonCCTrials@geisinger.edu   
Principal Investigator: Jagadeesh Ramdas         
Penn State Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Lisa M. McGregor         
Drexel University School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Site Public Contact    215-762-3950      
Principal Investigator: Gregory E. Halligan         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Richard B. Womer         
Saint Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Gregory E. Halligan         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jean M. Tersak         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Site Public Contact    401-444-1488      
Principal Investigator: Jennifer J. Greene Welch         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Site Public Contact    843-792-9321    hcc-clinical-trials@musc.edu   
Principal Investigator: Jacqueline M. Kraveka         
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Site Public Contact    803-434-3680      
Principal Investigator: Stuart L. Cramer         
Saint Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Contact: Site Public Contact    864-603-6213    meissa_beckman@bshsi.org   
Principal Investigator: Robert D. Siegel         
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nichole L. Bryant         
Saint Francis Cancer Center Recruiting
Greenville, South Carolina, United States, 29607
Contact: Site Public Contact    864-603-6213    meissa_beckman@bshsi.org   
Principal Investigator: Robert D. Siegel         
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Site Public Contact    605-312-3320    OncologyClinicalTrialsSF@SanfordHealth.org   
Principal Investigator: Kayelyn J. Wagner         
United States, Tennessee
T C Thompson Children's Hospital Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Manoo G. Bhakta         
Memorial Hospital Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Pulmonary Medicine Center of Chattanooga-Hixson Recruiting
Hixson, Tennessee, United States, 37343
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
East Tennessee Childrens Hospital Suspended
Knoxville, Tennessee, United States, 37916
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Sara M. Federico         
The Children's Hospital at TriStar Centennial Recruiting
Nashville, Tennessee, United States, 37203
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Haydar A. Frangoul         
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Site Public Contact    800-811-8480      
Principal Investigator: Scott C. Borinstein         
Memorial GYN Plus Recruiting
Ooltewah, Tennessee, United States, 37363
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
United States, Texas
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Amy C. Fowler         
Saint Joseph Regional Cancer Center Recruiting
Bryan, Texas, United States, 77802
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nkechi I. Mba         
Medical City Dallas Hospital Suspended
Dallas, Texas, United States, 75230
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Site Public Contact    214-648-7097    canceranswerline@UTSouthwestern.edu   
Principal Investigator: Patrick J. Leavey         
El Paso Children's Hospital Recruiting
El Paso, Texas, United States, 79905
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Lisa L. Hartman         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Karen H. Albritton         
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    713-798-1354    burton@bcm.edu   
Principal Investigator: Nino C. Rainusso Guainazzo         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    877-312-3961      
Principal Investigator: Najat C. Daw         
Covenant Children's Hospital Recruiting
Lubbock, Texas, United States, 79410
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Kishor M. Bhende         
University Medical Center Recruiting
Lubbock, Texas, United States, 79415
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mohamad M. Al-Rahawan         
Texas Tech University Health Sciences Center-Lubbock Recruiting
Lubbock, Texas, United States, 79430
Contact: Site Public Contact    806-775-8590      
Principal Investigator: Mohamad M. Al-Rahawan         
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Timothy C. Griffin         
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Vinod K. Gidvani-Diaz         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact    210-450-3800    phoresearchoffice@uthscsa.edu   
Principal Investigator: Anne-Marie R. Langevin         
Scott and White Memorial Hospital Suspended
Temple, Texas, United States, 76508
United States, Utah
Primary Children's Hospital Suspended
Salt Lake City, Utah, United States, 84113
United States, Vermont
Central Vermont Medical Center/National Life Cancer Treatment Recruiting
Berlin, Vermont, United States, 05602
Contact: Site Public Contact    802-225-5400      
Principal Investigator: Jessica L. Heath         
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Site Public Contact    802-656-4101      
Principal Investigator: Jessica L. Heath         
University of Vermont College of Medicine Recruiting
Burlington, Vermont, United States, 05405
Contact: Site Public Contact    802-656-8990      
Principal Investigator: Jessica L. Heath         
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Site Public Contact    703-208-6650    Stephanie.VanBebber@inova.org   
Principal Investigator: Marshall A. Schorin         
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eric J. Lowe         
Naval Medical Center - Portsmouth Active, not recruiting
Portsmouth, Virginia, United States, 23708-2197
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Site Public Contact       mwellons@vcu.edu   
Principal Investigator: India Y. Sisler         
Carilion Clinic Children's Hospital Recruiting
Roanoke, Virginia, United States, 24014
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mandy M. Atkinson         
United States, Washington
Harrison HealthPartners Hematology and Oncology-Bremerton Recruiting
Bremerton, Washington, United States, 98310
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Harrison Medical Center Recruiting
Bremerton, Washington, United States, 98310
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Highline Medical Center-Main Campus Recruiting
Burien, Washington, United States, 98166
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Saint Elizabeth Hospital Recruiting
Enumclaw, Washington, United States, 98022
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Saint Francis Hospital Recruiting
Federal Way, Washington, United States, 98003
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Saint Clare Hospital Recruiting
Lakewood, Washington, United States, 98499
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Harrison HealthPartners Hematology and Oncology-Poulsbo Recruiting
Poulsbo, Washington, United States, 98370
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Judy L. Felgenhauer         
Franciscan Research Center-Northwest Medical Plaza Recruiting
Tacoma, Washington, United States, 98405
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Mary Bridge Children's Hospital and Health Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Robert G. Irwin         
Northwest Medical Specialties PLLC Recruiting
Tacoma, Washington, United States, 98405
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Site Public Contact    253-968-0129    mamcdci@amedd.army.mil   
Principal Investigator: Melissa A. Forouhar         
United States, West Virginia
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Site Public Contact    304-293-7374    cancertrialsinfo@hsc.wvu.edu   
Principal Investigator: Stephan R. Paul         
United States, Wisconsin
Green Bay Oncology at Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: John R. Hill    920-433-8889    Christy.Gilchrist@hshs.org   
Principal Investigator: John R. Hill         
Saint Vincent Hospital Cancer Center Green Bay Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Site Public Contact    920-433-8889    Christy.Gilchrist@hshs.org   
Principal Investigator: Catherine A. Long         
Saint Vincent Hospital Cancer Center at Marinette Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Site Public Contact    920-433-8889    Christy.Gilchrist@hshs.org   
Principal Investigator: Catherine A. Long         
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Michael J. McManus         
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Site Public Contact    414-955-4727    MACCCTO@mcw.edu   
Principal Investigator: Meghen B. Browning         
Canada, Alberta
Alberta Children's Hospital Suspended
Calgary, Alberta, Canada, T3B 6A8
University of Alberta Hospital Suspended
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
British Columbia Children's Hospital Suspended
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba Suspended
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Child Health Centre Suspended
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre Suspended
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Suspended
Hamilton, Ontario, Canada, L8N 3Z5
Kingston Health Sciences Centre Suspended
Kingston, Ontario, Canada, K7L 2V7
Children's Hospital Suspended
London, Ontario, Canada, N6A 5W9
Children's Hospital of Eastern Ontario Suspended
Ottawa, Ontario, Canada, K1H 8L1
Hospital for Sick Children Suspended
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
The Montreal Children's Hospital of the MUHC Suspended
Montreal, Quebec, Canada, H3H 1P3
Centre Hospitalier Universitaire Sainte-Justine Suspended
Montreal, Quebec, Canada, H3T 1C5
Canada
Centre Hospitalier Universitaire de Quebec Suspended
Quebec, Canada, G1V 4G2
Puerto Rico
San Jorge Children's Hospital Recruiting
San Juan, Puerto Rico, 00912
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Luis A. Clavell         
University Pediatric Hospital Recruiting
San Juan, Puerto Rico, 00926
Contact: Site Public Contact    787-474-0333      
Principal Investigator: Luis A. Clavell         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven DuBois Children's Oncology Group

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02306161     History of Changes
Other Study ID Numbers: NCI-2014-02380
NCI-2014-02380 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AEWS1221
s15-00442
AEWS1221 ( Other Identifier: Childrens Oncology Group )
AEWS1221 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Neoplasms
Sarcoma
Sarcoma, Ewing
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplasm Metastasis
Lung Neoplasms
Soft Tissue Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Neoplastic Processes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases