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

This study is currently recruiting participants.
Verified November 2017 by National Cancer Institute (NCI)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02306161
First Posted: December 3, 2014
Last Update Posted: December 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to adverse analytic event (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:
  • 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.

  • Feasibility of SBRT, 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 [ Time Frame: Up to 10 years ]
    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.

  • 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.

  • Overall Survival [ Time Frame: From the time of randomization, assessed up to 10 years ]
  • Overall toxicity of the addition of ganitumab to VDC/IE chemotherapy, 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.

  • 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.

  • 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.

  • 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.


Other Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • Serum IGF pathway component and tissue protein, DNA, and 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.

  • 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.


Estimated Enrollment: 330
Actual Study Start Date: December 8, 2014
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Hide Detailed Description

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.

TERTIARY OBJECTIVES:

I. To compare bone marrow response rates and overall survival 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.

  Eligibility

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
  Contacts and Locations
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: Alyssa T. Reddy       helpdesk@childrensoncologygroup.org   
Principal Investigator: Alyssa T. Reddy         
University of South Alabama Recruiting
Mobile, Alabama, United States, 36604
Contact: Felicia L. Wilson    251-665-8000      
Principal Investigator: Felicia L. Wilson         
United States, Alaska
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Brenda J. Wittman    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: Erlyn C. Smith       helpdesk@childrensoncologygroup.org   
Principal Investigator: Erlyn C. Smith         
Phoenix Childrens Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Jessica Boklan    602-546-0920      
Principal Investigator: Jessica Boklan         
The University of Arizona Medical Center-University Campus Recruiting
Tucson, Arizona, United States, 85724
Contact: Lisa M. Kopp    520-626-9008      
Principal Investigator: Lisa M. Kopp         
Yuma Cancer Center Recruiting
Yuma, Arizona, United States, 85364
Contact: Lisa M. Kopp    520-626-9008      
Principal Investigator: Lisa M. Kopp         
United States, Arkansas
Mercy Cancer Center-Hot Springs Recruiting
Hot Springs, Arkansas, United States, 71913
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: David L. Becton    501-686-8274      
Principal Investigator: David L. Becton         
United States, California
Southern California Permanente Medical Group Suspended
Downey, California, United States, 90242
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Anna B. Pawlowska    800-826-4673    becomingapatient@coh.org   
Principal Investigator: Anna B. Pawlowska         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Albert Kheradpour    909-558-3375      
Principal Investigator: Albert Kheradpour         
Miller Children's and Women's Hospital Long Beach Recruiting
Long Beach, California, United States, 90806
Contact: Pamela H. Kempert       helpdesk@childrensoncologygroup.org   
Principal Investigator: Pamela H. Kempert         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas       helpdesk@childrensoncologygroup.org   
Principal Investigator: Leo Mascarenhas         
Children's Hospital Central California Recruiting
Madera, California, United States, 93636-8762
Contact: Vonda L. Crouse       helpdesk@childrensoncologygroup.org   
Principal Investigator: Vonda L. Crouse         
Children's Hospital and Research Center at Oakland Recruiting
Oakland, California, United States, 94609-1809
Contact: Carla B. Golden       helpdesk@childrensoncologygroup.org   
Principal Investigator: Carla B. Golden         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Steven K. Bergstrom    510-891-3400      
Principal Investigator: Steven K. Bergstrom         
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Elyssa M. Rubin       helpdesk@childrensoncologygroup.org   
Principal Investigator: Elyssa M. Rubin         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Sheri L. Spunt    650-498-7061    ccto-office@stanford.edu   
Principal Investigator: Sheri L. Spunt         
Sutter Medical Center Sacramento Recruiting
Sacramento, California, United States, 95816
Contact: Yung S. Yim    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: Marcio H. Malogolowkin    916-734-3089      
Principal Investigator: Marcio H. Malogolowkin         
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: William D. Roberts       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: Robert E. Goldsby    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: Eduard H. Panosyan    310-222-3621      
Principal Investigator: Eduard H. Panosyan         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Timothy P. Garrington       helpdesk@childrensoncologygroup.org   
Principal Investigator: Timothy P. Garrington         
Penrose-Saint Francis Healthcare Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Rocky Mountain Cancer Centers-Penrose Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Jennifer J. Clark       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jennifer J. Clark         
Mercy Medical Center Recruiting
Durango, Colorado, United States, 81301
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Southwest Oncology PC Recruiting
Durango, Colorado, United States, 81301
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Mountain Blue Cancer Care Center Recruiting
Golden, Colorado, United States, 80401
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Rocky Mountain Cancer Centers-Lakewood Recruiting
Lakewood, Colorado, United States, 80228
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Saint Anthony Hospital Recruiting
Lakewood, Colorado, United States, 80228
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Littleton Adventist Hospital Recruiting
Littleton, Colorado, United States, 80122
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Longmont United Hospital Recruiting
Longmont, Colorado, United States, 80501
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Rocky Mountain Cancer Centers-Longmont Recruiting
Longmont, Colorado, United States, 80501
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Parker Adventist Hospital Recruiting
Parker, Colorado, United States, 80138
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Rocky Mountain Cancer Centers-Parker Recruiting
Parker, Colorado, United States, 80138
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Saint Mary Corwin Medical Center Recruiting
Pueblo, Colorado, United States, 81004
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Rocky Mountain Cancer Centers - Pueblo Recruiting
Pueblo, Colorado, United States, 81008
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Rocky Mountain Cancer Centers-Thornton Recruiting
Thornton, Colorado, United States, 80260
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Michael S. Isakoff    800-579-7822      
Principal Investigator: Michael S. Isakoff         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Nina S. Kadan-Lottick    203-785-5702      
Principal Investigator: Nina S. Kadan-Lottick         
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Scott M. Bradfield       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Corina E. Gonzalez    202-444-2223      
Principal Investigator: Corina E. Gonzalez         
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Jeffrey S. Dome       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: Emad K. Salman    877-680-0008      
Principal Investigator: Emad K. Salman         
University of Florida Health Science Center - Gainesville Recruiting
Gainesville, Florida, United States, 32610
Contact: William B. Slayton    352-273-8675    trials@cancer.ufl.edu   
Principal Investigator: William B. Slayton         
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Iftikhar Hanif       helpdesk@childrensoncologygroup.org   
Principal Investigator: Iftikhar Hanif         
Nemours Children's Clinic-Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Scott M. Bradfield       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: Julio C. Barredo    305-243-2647      
Principal Investigator: Julio C. Barredo         
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Enrique A. Escalon       helpdesk@childrensoncologygroup.org   
Principal Investigator: Enrique A. Escalon         
Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Fouad M. Hajjar    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: Vincent F. Giusti    321-841-7246    CancerClinicalTrials@orlandohealth.com   
Principal Investigator: Vincent F. Giusti         
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Scott M. Bradfield       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Scott M. Bradfield       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
Johns Hopkins All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Jonathan L. Metts       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: Narayana Gowda       helpdesk@childrensoncologygroup.org   
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: William T. Cash       helpdesk@childrensoncologygroup.org   
Principal Investigator: William T. Cash         
Augusta University Medical Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Colleen H. McDonough    706-721-1663    cancer@augusta.edu   
Principal Investigator: Colleen H. McDonough         
Memorial University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: J. M. Johnston    912-350-8568      
Principal Investigator: J. M. Johnston         
United States, Hawaii
Straub Clinic and Hospital Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Wade T. Kyono    808-586-2979      
Principal Investigator: Wade T. Kyono         
Kaiser Permanente Moanalua Medical Center Recruiting
Honolulu, Hawaii, United States, 96819
Contact: Wade T. Kyono    808-586-2979      
Principal Investigator: Wade T. Kyono         
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Wade T. Kyono    808-586-2979      
Principal Investigator: Wade T. Kyono         
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Eugenia Chang       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eugenia Chang         
United States, Illinois
Rush - Copley Medical Center Recruiting
Aurora, Illinois, United States, 60504
Contact: Yujie Zhao    630-978-6212    Cancer.Research@rushcopley.com   
Principal Investigator: Yujie Zhao         
Lurie Children's Hospital-Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: David O. Walterhouse       helpdesk@childrensoncologygroup.org   
Principal Investigator: David O. Walterhouse         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary L. Schmidt    312-355-3046      
Principal Investigator: Mary L. Schmidt         
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Susan L. Cohn    773-834-7424      
Principal Investigator: Susan L. Cohn         
Carle on Vermilion Recruiting
Danville, Illinois, United States, 61832
Contact: Yujie Zhao    630-978-6212    Cancer.Research@rushcopley.com   
Principal Investigator: Yujie Zhao         
Carle Physician Group-Effingham Recruiting
Effingham, Illinois, United States, 62401
Contact: Yujie Zhao    630-978-6212    Cancer.Research@rushcopley.com   
Principal Investigator: Yujie Zhao         
Carle Physician Group-Mattoon/Charleston Recruiting
Mattoon, Illinois, United States, 61938
Contact: Yujie Zhao    630-978-6212    Cancer.Research@rushcopley.com   
Principal Investigator: Yujie Zhao         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Eugene Suh    708-226-4357      
Principal Investigator: Eugene Suh         
Good Samaritan Regional Health Center Recruiting
Mount Vernon, Illinois, United States, 62864
Contact: Jay W. Carlson    888-221-4849      
Principal Investigator: Jay W. Carlson         
Advocate Children's Hospital-Oak Lawn Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Rebecca E. McFall       helpdesk@childrensoncologygroup.org   
Principal Investigator: Rebecca E. McFall         
Advocate Children's Hospital-Park Ridge Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Caroline Y. Hu    847-384-3621      
Principal Investigator: Caroline Y. Hu         
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Pedro A. De Alarcon    888-226-4343      
Principal Investigator: Pedro A. De Alarcon         
Saint John's Hospital Recruiting
Springfield, Illinois, United States, 62702
Contact: Gregory P. Brandt    217-545-7929      
Principal Investigator: Gregory P. Brandt         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Gregory P. Brandt    217-545-7929      
Principal Investigator: Gregory P. Brandt         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Contact: Gregory P. Brandt    217-545-7929      
Principal Investigator: Gregory P. Brandt         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Yujie Zhao    630-978-6212    Cancer.Research@rushcopley.com   
Principal Investigator: Yujie Zhao         
The Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
Contact: Yujie Zhao    630-978-6212    Cancer.Research@rushcopley.com   
Principal Investigator: Yujie Zhao         
Rush-Copley Healthcare Center Recruiting
Yorkville, Illinois, United States, 60560
Contact: Yujie Zhao    630-978-6212    Cancer.Research@rushcopley.com   
Principal Investigator: Yujie Zhao         
United States, Indiana
Deaconess Clinic Downtown Recruiting
Evansville, Indiana, United States, 47713
Contact: Yujie Zhao    877-654-0311      
Principal Investigator: Yujie Zhao         
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kamnesh R. Pradhan    800-248-1199      
Principal Investigator: Kamnesh R. Pradhan         
Saint Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Bassem I. Razzouk    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: Yujie Zhao    812-426-9576      
Principal Investigator: Yujie Zhao         
United States, Iowa
Medical Oncology and Hematology Associates-West Des Moines Recruiting
Clive, Iowa, United States, 50325
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Mercy Cancer Center-West Lakes Recruiting
Clive, Iowa, United States, 50325
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Alegent Health Mercy Hospital Recruiting
Council Bluffs, Iowa, United States, 51503
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Greater Regional Medical Center Recruiting
Creston, Iowa, United States, 50801
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Wendy L. Woods-Swafford    515-241-3305    rbehrens@cancercenterofiowa.com   
Principal Investigator: Wendy L. Woods-Swafford         
Medical Oncology and Hematology Associates-Laurel Recruiting
Des Moines, Iowa, United States, 50314
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mariko Sato    800-237-1225      
Principal Investigator: Mariko Sato         
Mercy Medical Center-West Lakes Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
United States, Kentucky
Flaget Memorial Hospital Recruiting
Bardstown, Kentucky, United States, 40004
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Commonwealth Cancer Center-Corbin Recruiting
Corbin, Kentucky, United States, 40701
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Saint Joseph Radiation Oncology Resource Center Recruiting
Lexington, Kentucky, United States, 40504
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Saint Joseph Hospital East Recruiting
Lexington, Kentucky, United States, 40509
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Lars M. Wagner    859-257-3379      
Principal Investigator: Lars M. Wagner         
Jewish Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Norton Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Ashok B. Raj    866-530-5516      
Principal Investigator: Ashok B. Raj         
Saints Mary and Elizabeth Hospital Recruiting
Louisville, Kentucky, United States, 40215
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Jewish Hospital Medical Center Northeast Recruiting
Louisville, Kentucky, United States, 40245
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Jewish Hospital Medical Center South Recruiting
Shepherdsville, Kentucky, United States, 40165
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
United States, Louisiana
Children's Hospital New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Lolie C. Yu       helpdesk@childrensoncologygroup.org   
Principal Investigator: Lolie C. Yu         
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Craig Lotterman    504-842-3708      
Principal Investigator: Craig Lotterman         
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Nadine P. SantaCruz    207-973-4274      
Principal Investigator: Nadine P. SantaCruz         
Maine Children's Cancer Program Recruiting
Scarborough, Maine, United States, 04074
Contact: Aaron R. Weiss       helpdesk@childrensoncologygroup.org   
Principal Investigator: Aaron R. Weiss         
United States, Maryland
University of Maryland/Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Teresa A. York    800-888-8823      
Principal Investigator: Teresa A. York         
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Jason M. Fixler    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: Nicolas J. Llosa    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: Kenneth H. Lieuw    301-319-2100      
Principal Investigator: Kenneth H. Lieuw         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Steven G. DuBois    877-827-3222      
Principal Investigator: Steven G. DuBois         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Steven G. DuBois    877-827-3222      
Principal Investigator: Steven G. DuBois         
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Joanna G. Luty    413-794-3565    tamara.wrenn@baystatehealth.org   
Principal Investigator: Joanna G. Luty         
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Christopher P. Keuker    508-856-6265      
Principal Investigator: Christopher P. Keuker         
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Rama Jasty       helpdesk@childrensoncologygroup.org   
Principal Investigator: Rama Jasty         
Bronson Battle Creek Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Kathleen J. Yost    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: Roland L. Chu    313-576-9363      
Principal Investigator: Roland L. Chu         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Adonis N. Lorenzana    313-343-3166      
Principal Investigator: Adonis N. Lorenzana         
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Nkechi Onwuzurike    810-762-8057      
Principal Investigator: Nkechi Onwuzurike         
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Kathleen J. Yost    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Mercy Health Saint Mary's Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Kathleen J. Yost    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Kathleen J. Yost    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Kathleen J. Yost    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Kathleen J. Yost    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Kathleen J. Yost    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Mercy Health Mercy Campus Recruiting
Muskegon, Michigan, United States, 49444
Contact: Kathleen J. Yost    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Lakeland Community Hospital Recruiting
Niles, Michigan, United States, 49120
Contact: Kathleen J. Yost    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Lake Huron Medical Center Recruiting
Port Huron, Michigan, United States, 48060
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
Spectrum Health Reed City Hospital Recruiting
Reed City, Michigan, United States, 49677
Contact: Kathleen J. Yost    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: Laura K. Gowans    248-551-7695      
Principal Investigator: Laura K. Gowans         
Lakeland Hospital Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Kathleen J. Yost    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Marie Yeager Cancer Center Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Kathleen J. Yost    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Kathleen J. Yost    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: Emily G. Greengard    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Emily G. Greengard         
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Michael K. Richards       helpdesk@childrensoncologygroup.org   
Principal Investigator: Michael K. Richards         
University of Minnesota/Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Emily G. Greengard       helpdesk@childrensoncologygroup.org   
Principal Investigator: Emily G. Greengard         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Nadia N. Laack    855-776-0015      
Principal Investigator: Nadia N. Laack         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Anderson (Andy) B. Collier    601-815-6700      
Principal Investigator: Anderson (Andy) B. Collier         
United States, Missouri
Central Care Cancer Center-Carrie J Babb Cancer Center Recruiting
Bolivar, Missouri, United States, 65613
Contact: Jay W. Carlson    888-221-4849      
Principal Investigator: Jay W. Carlson         
CoxHealth Cancer Center Recruiting
Branson, Missouri, United States, 65616
Contact: Jay W. Carlson    888-221-4849      
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: Jay W. Carlson    888-221-4849      
Principal Investigator: Jay W. Carlson         
Mercy Hospital-Joplin Recruiting
Joplin, Missouri, United States, 64804
Contact: Jay W. Carlson    888-221-4849      
Principal Investigator: Jay W. Carlson         
The Childrens Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Keith J. August       helpdesk@childrensoncologygroup.org   
Principal Investigator: Keith J. August         
Delbert Day Cancer Institute at PCRMC Recruiting
Rolla, Missouri, United States, 65401
Contact: Jay W. Carlson    888-221-4849      
Principal Investigator: Jay W. Carlson         
Saint John's Clinic-Rolla-Cancer and Hematology Recruiting
Rolla, Missouri, United States, 65401
Contact: Jay W. Carlson    888-221-4849      
Principal Investigator: Jay W. Carlson         
Heartland Regional Medical Center Recruiting
Saint Joseph, Missouri, United States, 64506
Contact: Jay W. Carlson    913-948-5588    aroland@kccop.org   
Principal Investigator: Jay W. Carlson         
Cardinal Glennon Children's Medical Center Recruiting
Saint Louis, Missouri, United States, 63104
Contact: William S. Ferguson       helpdesk@childrensoncologygroup.org   
Principal Investigator: William S. Ferguson         
Saint Louis Cancer and Breast Institute-South City Recruiting
Saint Louis, Missouri, United States, 63109
Contact: Jay W. Carlson    888-221-4849      
Principal Investigator: Jay W. Carlson         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Frederick S. Huang    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Frederick S. Huang         
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Jay W. Carlson    888-221-4849      
Principal Investigator: Jay W. Carlson         
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay W. Carlson    888-221-4849      
Principal Investigator: Jay W. Carlson         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay W. Carlson    888-221-4849      
Principal Investigator: Jay W. Carlson         
United States, Nebraska
CHI Health Saint Francis Recruiting
Grand Island, Nebraska, United States, 68803
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Heartland Hematology and Oncology Recruiting
Kearney, Nebraska, United States, 68845
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
CHI Health Good Samaritan Recruiting
Kearney, Nebraska, United States, 68847
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Saint Elizabeth Regional Medical Center Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Minnie Abromowitch       helpdesk@childrensoncologygroup.org   
Principal Investigator: Minnie Abromowitch         
Alegent Health Immanuel Medical Center Recruiting
Omaha, Nebraska, United States, 68122
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Hemotology and Oncology Consultants PC Recruiting
Omaha, Nebraska, United States, 68122
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Alegent Health Bergan Mercy Medical Center Recruiting
Omaha, Nebraska, United States, 68124
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Alegent Health Lakeside Hospital Recruiting
Omaha, Nebraska, United States, 68130
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Creighton University Medical Center Recruiting
Omaha, Nebraska, United States, 68131
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Minnie Abromowitch       helpdesk@childrensoncologygroup.org   
Principal Investigator: Minnie Abromowitch         
Midlands Community Hospital Recruiting
Papillion, Nebraska, United States, 68046
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
United States, Nevada
Carson Tahoe Regional Medical Center Recruiting
Carson City, Nevada, United States, 89703
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Nik Farahana N. Rashid    702-384-0013      
Principal Investigator: Nik Farahana N. Rashid         
Children's Specialty Center of Nevada II Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
Sunrise Hospital and Medical Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
Ann M Wierman MD LTD Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
Summerlin Hospital Medical Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
Hope Cancer Care of Nevada-Pahrump Recruiting
Pahrump, Nevada, United States, 89048
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
Saint Mary's Regional Medical Center Recruiting
Reno, Nevada, United States, 89503
Contact: Alan K. Ikeda    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Alan K. Ikeda         
Radiation Oncology Associates Recruiting
Reno, Nevada, United States, 89509
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Sara Chaffee    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: Michael B. Harris    201-996-2879      
Principal Investigator: Michael B. Harris         
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Steven L. Halpern    201-996-2879      
Principal Investigator: Steven L. Halpern         
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Nibal A. Zaghloul       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: Richard A. Drachtman    732-235-8675      
Principal Investigator: Richard A. Drachtman         
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Peri Kamalakar    973-926-7230      
Principal Investigator: Peri Kamalakar         
Saint Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Mary A. Bonilla       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mary A. Bonilla         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Vikramjit S. Kanwar    518-262-3368      
Principal Investigator: Vikramjit S. Kanwar         
Montefiore Medical Center-Einstein Campus Recruiting
Bronx, New York, United States, 10461
Contact: Lisa Gennarini    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Lisa Gennarini         
Montefiore Medical Center-Weiler Hospital Recruiting
Bronx, New York, United States, 10461
Contact: Lisa Gennarini    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Lisa Gennarini         
Montefiore Medical Center - Moses Campus Recruiting
Bronx, New York, United States, 10467-2490
Contact: Lisa Gennarini    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Lisa Gennarini         
Children's Hospital at Montefiore Recruiting
Bronx, New York, United States, 10467
Contact: Lisa Gennarini    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Lisa Gennarini         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Lynda K. Beaupin    877-275-7724      
Principal Investigator: Lynda K. Beaupin         
Glens Falls Hospital Recruiting
Glens Falls, New York, United States, 12801
Contact: Alan C. Homans    802-656-8990      
Principal Investigator: Alan C. Homans         
NYU Winthrop Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Mark E. Weinblatt    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: Arlene S. Redner       helpdesk@childrensoncologygroup.org   
Principal Investigator: Arlene S. Redner         
Laura and Isaac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Sharon L. Gardner    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Sharon L. Gardner         
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Birte Wistinghausen    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: Alice Lee    212-305-8615      
Principal Investigator: Alice Lee         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Jeffrey R. Andolina    585-275-5830      
Principal Investigator: Jeffrey R. Andolina         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Laura E. Hogan    800-862-2215      
Principal Investigator: Laura E. Hogan         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Philip M. Monteleone    315-464-5476      
Principal Investigator: Philip M. Monteleone         
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Jessica C. Hochberg    914-594-3794      
Principal Investigator: Jessica C. Hochberg         
United States, North Carolina
Mission Hospital-Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Douglas J. Scothorn    828-213-4150      
Principal Investigator: Douglas J. Scothorn         
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Stuart H. Gold    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Stuart H. Gold         
Carolinas Medical Center/Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Joel A. Kaplan    704-355-2884      
Principal Investigator: Joel A. Kaplan         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Susan G. Kreissman    888-275-3853      
Principal Investigator: Susan G. Kreissman         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Thomas B. Russell    336-713-6771      
Principal Investigator: Thomas B. Russell         
United States, North Dakota
Sanford Broadway Medical Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Samuel O. Anim    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: Steven J. Kuerbitz       helpdesk@childrensoncologygroup.org   
Principal Investigator: Steven J. Kuerbitz         
Good Samaritan Hospital - Cincinnati Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Joseph G. Pressey       helpdesk@childrensoncologygroup.org   
Principal Investigator: Joseph G. Pressey         
Bethesda North Hospital Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
TriHealth Cancer Institute-Westside Recruiting
Cincinnati, Ohio, United States, 45247
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
TriHealth Cancer Institute-Anderson Recruiting
Cincinnati, Ohio, United States, 45255
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Yousif (Joe) H. Matloub    216-844-5437      
Principal Investigator: Yousif (Joe) H. Matloub         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Aron Flagg    866-223-8100      
Principal Investigator: Aron Flagg         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Mark A. Ranalli       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mark A. Ranalli         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Ayman A. El-Sheikh       helpdesk@childrensoncologygroup.org   
Principal Investigator: Ayman A. El-Sheikh         
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Jamie L. Dargart    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: Rene Y. McNall-Knapp    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: Jay W. Carlson    888-221-4849      
Principal Investigator: Jay W. Carlson         
United States, Oregon
Legacy Emanuel Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Janice F. Olson    503-413-8199      
Principal Investigator: Janice F. Olson         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Suman Malempati    503-494-1080    trials@ohsu.edu   
Principal Investigator: Suman Malempati         
United States, Pennsylvania
Lehigh Valley Hospital-Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Lydia A. Boateng    484-884-2201      
Principal Investigator: Lydia A. Boateng         
Lehigh Valley Hospital - Muhlenberg Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Lydia A. Boateng    484-884-2201      
Principal Investigator: Lydia A. Boateng         
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Jagadeesh Ramdas    570-271-5251      
Principal Investigator: Jagadeesh Ramdas         
Penn State Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Lisa M. McGregor       helpdesk@childrensoncologygroup.org   
Principal Investigator: Lisa M. McGregor         
Drexel University School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Gregory E. Halligan    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Gregory E. Halligan         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Richard B. Womer       helpdesk@childrensoncologygroup.org   
Principal Investigator: Richard B. Womer         
Saint Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Gregory E. Halligan       helpdesk@childrensoncologygroup.org   
Principal Investigator: Gregory E. Halligan         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Jean M. Tersak       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jean M. Tersak         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Jennifer J. Greene Welch    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: Jacqueline M. Kraveka    843-792-9321      
Principal Investigator: Jacqueline M. Kraveka         
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Stuart L. Cramer    803-434-3680      
Principal Investigator: Stuart L. Cramer         
Saint Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Contact: Robert D. Siegel    864-255-1713      
Principal Investigator: Robert D. Siegel         
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Nichole L. Bryant       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nichole L. Bryant         
Saint Francis Cancer Center Recruiting
Greenville, South Carolina, United States, 29607
Contact: Robert D. Siegel    864-255-1713      
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: Kayelyn J. Wagner    605-328-1367      
Principal Investigator: Kayelyn J. Wagner         
United States, Tennessee
T C Thompson Children's Hospital Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Manoo G. Bhakta       helpdesk@childrensoncologygroup.org   
Principal Investigator: Manoo G. Bhakta         
Memorial Hospital Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Pulmonary Medicine Center of Chattanooga-Hixson Recruiting
Hixson, Tennessee, United States, 37343
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
East Tennessee Childrens Hospital Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Ray C. Pais    865-541-8266      
Principal Investigator: Ray C. Pais         
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Sara M. Federico       helpdesk@childrensoncologygroup.org   
Principal Investigator: Sara M. Federico         
The Children's Hospital at TriStar Centennial Recruiting
Nashville, Tennessee, United States, 37203
Contact: Haydar A. Frangoul    800-811-8480      
Principal Investigator: Haydar A. Frangoul         
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Scott C. Borinstein    800-811-8480      
Principal Investigator: Scott C. Borinstein         
Memorial GYN Plus Recruiting
Ooltewah, Tennessee, United States, 37363
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
United States, Texas
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Amy C. Fowler       helpdesk@childrensoncologygroup.org   
Principal Investigator: Amy C. Fowler         
Saint Joseph Regional Cancer Center Recruiting
Bryan, Texas, United States, 77802
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Nkechi I. Mba       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nkechi I. Mba         
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Stanton C. Goldman    972-566-5588      
Principal Investigator: Stanton C. Goldman         
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Patrick J. Leavey    214-648-7097      
Principal Investigator: Patrick J. Leavey         
El Paso Children's Hospital Recruiting
El Paso, Texas, United States, 79905
Contact: Lisa L. Hartman       helpdesk@childrensoncologygroup.org   
Principal Investigator: Lisa L. Hartman         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Karen H. Albritton    800-422-9567      
Principal Investigator: Karen H. Albritton         
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Nino C. Rainusso Guainazzo    713-798-1354    burton@bcm.edu   
Principal Investigator: Nino C. Rainusso Guainazzo         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Najat C. Daw    713-792-3245      
Principal Investigator: Najat C. Daw         
Covenant Children's Hospital Recruiting
Lubbock, Texas, United States, 79410
Contact: Kishor M. Bhende    806-775-8590      
Principal Investigator: Kishor M. Bhende         
University Medical Center Recruiting
Lubbock, Texas, United States, 79415
Contact: Mohamad M. Al-Rahawan    309-655-3258      
Principal Investigator: Mohamad M. Al-Rahawan         
Texas Tech University Health Sciences Center-Lubbock Recruiting
Lubbock, Texas, United States, 79430
Contact: Mohamad M. Al-Rahawan    309-655-3258      
Principal Investigator: Mohamad M. Al-Rahawan         
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Timothy C. Griffin    800-248-1199      
Principal Investigator: Timothy C. Griffin         
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Vinod K. Gidvani-Diaz       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: Anne-Marie R. Langevin    210-450-3800    CTO@uthscsa.edu   
Principal Investigator: Anne-Marie R. Langevin         
Scott and White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Guy H. Grayson    254-724-5407      
Principal Investigator: Guy H. Grayson         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Phillip E. Barnette       helpdesk@childrensoncologygroup.org   
Principal Investigator: Phillip E. Barnette         
United States, Vermont
Central Vermont Medical Center/National Life Cancer Treatment Recruiting
Berlin, Vermont, United States, 05602
Contact: Alan C. Homans    802-656-8990      
Principal Investigator: Alan C. Homans         
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Alan C. Homans    802-656-8990      
Principal Investigator: Alan C. Homans         
University of Vermont College of Medicine Recruiting
Burlington, Vermont, United States, 05405
Contact: Alan C. Homans    802-656-8990      
Principal Investigator: Alan C. Homans         
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Marshall A. Schorin    703-208-6650    Stephanie.VanBebber@inova.org   
Principal Investigator: Marshall A. Schorin         
Childrens Hospital-King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Eric J. Lowe       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: India Y. Sisler    800-811-8480      
Principal Investigator: India Y. Sisler         
Carilion Clinic Children's Hospital Recruiting
Roanoke, Virginia, United States, 24014
Contact: Mandy M. Atkinson       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mandy M. Atkinson         
United States, Washington
Harrison HealthPartners Hematology and Oncology-Bremerton Recruiting
Bremerton, Washington, United States, 98310
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Harrison Medical Center Recruiting
Bremerton, Washington, United States, 98310
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Highline Medical Center-Main Campus Recruiting
Burien, Washington, United States, 98166
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Saint Elizabeth Hospital Recruiting
Enumclaw, Washington, United States, 98022
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Saint Francis Hospital Recruiting
Federal Way, Washington, United States, 98003
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Saint Clare Hospital Recruiting
Lakewood, Washington, United States, 98499
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Harrison HealthPartners Hematology and Oncology-Poulsbo Recruiting
Poulsbo, Washington, United States, 98370
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Douglas S. Hawkins       helpdesk@childrensoncologygroup.org   
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Judy L. Felgenhauer       helpdesk@childrensoncologygroup.org   
Principal Investigator: Judy L. Felgenhauer         
Franciscan Research Center-Northwest Medical Plaza Recruiting
Tacoma, Washington, United States, 98405
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Mary Bridge Children's Hospital and Health Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Robert G. Irwin       helpdesk@childrensoncologygroup.org   
Principal Investigator: Robert G. Irwin         
Northwest Medical Specialties PLLC Recruiting
Tacoma, Washington, United States, 98405
Contact: Mehmet S. Copur    501-622-2100      
Principal Investigator: Mehmet S. Copur         
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Melissa A. Forouhar    301-319-2100      
Principal Investigator: Melissa A. Forouhar         
United States, West Virginia
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Stephan R. Paul    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: John R. Hill    920-433-8889    Christy.Gilchrist@hshs.org   
Principal Investigator: John R. Hill         
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Michael J. McManus    715-389-4457      
Principal Investigator: Michael J. McManus         
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Meghen B. Browning    414-805-4380      
Principal Investigator: Meghen B. Browning         
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Sarah J. McKillop    780-407-6615    val.taylor@albertahealthservices.ca   
Principal Investigator: Sarah J. McKillop         
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: David B. Dix       helpdesk@childrensoncologygroup.org   
Principal Investigator: David B. Dix         
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Tanya R. Brown    306-766-2213      
Principal Investigator: Tanya R. Brown         
Canada, Newfoundland and Labrador
Janeway Child Health Centre Recruiting
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Lisa Anne B. Goodyear    866-722-1126      
Principal Investigator: Lisa Anne B. Goodyear         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Conrad V. Fernandez    902-470-8394      
Principal Investigator: Conrad V. Fernandez         
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol Portwine       helpdesk@childrensoncologygroup.org   
Principal Investigator: Carol Portwine         
Kingston Health Sciences Centre Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Mariana P. Silva    613-544-2630      
Principal Investigator: Mariana P. Silva         
Children's Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Shayna M. Zelcer       helpdesk@childrensoncologygroup.org   
Principal Investigator: Shayna M. Zelcer         
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Donna L. Johnston       helpdesk@childrensoncologygroup.org   
Principal Investigator: Donna L. Johnston         
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Abha A. Gupta    416-946-4501    clinical.trials@uhn.on.ca   
Principal Investigator: Abha A. Gupta         
Canada, Quebec
The Montreal Children's Hospital of the MUHC Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Sharon B. Abish       helpdesk@childrensoncologygroup.org   
Principal Investigator: Sharon B. Abish         
Centre Hospitalier Universitaire Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Yvan Samson    514-345-4931      
Principal Investigator: Yvan Samson         
Canada
Centre Hospitalier Universitaire de Quebec Recruiting
Quebec, Canada, G1V 4G2
Contact: Bruno Michon       helpdesk@childrensoncologygroup.org   
Principal Investigator: Bruno Michon         
Puerto Rico
San Jorge Children's Hospital Recruiting
San Juan, Puerto Rico, 00912
Contact: Luis A. Clavell       helpdesk@childrensoncologygroup.org   
Principal Investigator: Luis A. Clavell         
University Pediatric Hospital Recruiting
San Juan, Puerto Rico, 00926
Contact: Luis A. Clavell       helpdesk@childrensoncologygroup.org   
Principal Investigator: Luis A. Clavell         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven DuBois Children's Oncology Group
  More Information

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 Submitted: December 1, 2014
First Posted: December 3, 2014
Last Update Posted: December 15, 2017
Last Verified: November 2017

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