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Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Hydrochloride Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT02180867
Recruitment Status : Suspended (Scheduled Interim Monitoring)
First Posted : July 3, 2014
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This randomized phase II/III trial studies how well pazopanib hydrochloride, combination chemotherapy, and radiation therapy work and compares it to radiation therapy alone or in combination with pazopanib hydrochloride or combination chemotherapy in treating patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can be removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin hydrochloride, 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. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy works better when given with or without combination chemotherapy and/or pazopanib hydrochloride in treating patients with non-rhabdomyosarcoma soft tissue sarcomas.

Condition or disease Intervention/treatment Phase
Adult Fibrosarcoma Alveolar Soft Part Sarcoma Angiomatoid Fibrous Histiocytoma Atypical Fibroxanthoma Clear Cell Sarcoma of Soft Tissue Epithelioid Malignant Peripheral Nerve Sheath Tumor Epithelioid Sarcoma Extraskeletal Myxoid Chondrosarcoma Extraskeletal Osteosarcoma Fibrohistiocytic Neoplasm Glomus Tumor of the Skin Inflammatory Myofibroblastic Tumor Intimal Sarcoma Leiomyosarcoma Liposarcoma Low Grade Fibromyxoid Sarcoma Low Grade Myofibroblastic Sarcoma Malignant Cutaneous Granular Cell Tumor Malignant Peripheral Nerve Sheath Tumor Malignant Triton Tumor Mesenchymal Chondrosarcoma Myxofibrosarcoma Myxoid Chondrosarcoma Myxoinflammatory Fibroblastic Sarcoma Nerve Sheath Neoplasm PEComa Pericytic Neoplasm Plexiform Fibrohistiocytic Tumor Sclerosing Epithelioid Fibrosarcoma Stage IB Soft Tissue Sarcoma AJCC v7 Stage IIB Soft Tissue Sarcoma AJCC v7 Stage III Soft Tissue Sarcoma AJCC v7 Stage IV Soft Tissue Sarcoma AJCC v7 Synovial Sarcoma Undifferentiated (Embryonal) Sarcoma Undifferentiated High Grade Pleomorphic Sarcoma of Bone Drug: Doxorubicin Hydrochloride Drug: Ifosfamide Other: Laboratory Biomarker Analysis Drug: Pazopanib Hydrochloride Other: Pharmacological Study Radiation: Radiation Therapy Procedure: Therapeutic Conventional Surgery Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754)
Actual Study Start Date : July 11, 2014
Estimated Primary Completion Date : March 15, 2020


Arm Intervention/treatment
Experimental: Regimen A (pazopanib hydrochloride, chemoradiation)
See Regimen A Detailed Description.
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: 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

Drug: Pazopanib Hydrochloride
Given PO
Other Names:
  • GW786034B
  • Votrient

Other: Pharmacological Study
Correlative studies

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation

Procedure: Therapeutic Conventional Surgery
Undergo surgery

Experimental: Regimen B (chemoradiation)
See Regimen B Detailed Description.
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: 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: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation

Procedure: Therapeutic Conventional Surgery
Undergo surgery

Experimental: Regimen C (pazopanib hydrochloride, radiation therapy)

INDUCTION PHASE: Patients receive pazopanib hydrochloride PO QD on weeks 1-9. Patients undergo radiation therapy on weeks 1-7.

SURGERY: Patients undergo surgery on week 10.

CONTINUATION PHASE: Patients receive pazopanib hydrochloride PO QD on weeks 13-25. Patients undergo radiation therapy on weeks 13-16 for a total of 50 Gy. Patients with impaired wound healing within 8 weeks of the date of surgery, are removed from protocol therapy effective the date 8 weeks after week 10 surgery.

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Pazopanib Hydrochloride
Given PO
Other Names:
  • GW786034B
  • Votrient

Other: Pharmacological Study
Correlative studies

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation

Procedure: Therapeutic Conventional Surgery
Undergo surgery

Experimental: Regimen D (radiation therapy)

INDUCTION PHASE: Patients undergo radiation therapy on weeks 1-7.

SURGERY: Patients undergo surgery on week 10.

CONTINUATION PHASE: Patients undergo radiation therapy on weeks 13-16 for a total of 50 Gy. Patients with impaired wound healing within 8 weeks of the date of surgery, are removed from protocol therapy effective the date 8 weeks after week 10 surgery.

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacological Study
Correlative studies

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation

Procedure: Therapeutic Conventional Surgery
Undergo surgery




Primary Outcome Measures :
  1. Potential benefit for chemoradiotherapy plus pazopanib hydrochloride defined as protocol week 13 pathologic response (Phase II) [ Time Frame: Week 13 ]
    The expected null (chemotherapy only) pathologic response rate (90%+ necrosis at week 13) is 40%.

  2. Potential benefit for radiotherapy plus pazopanib hydrochloride defined as protocol week 10 pathologic response (Phase II/III) [ Time Frame: Week 10 ]
    The expected null (radiation therapy only) pathologic response rate (90%+ necrosis at Week 10) is 10%.

  3. Event-free survival (EFS) (Phase III) [ Time Frame: Time to the first occurrence of progression, relapse after response, secondary cancer or death from any cause, assessed up to 60 months ]
    The null (radiation therapy only) 5-year EFS for patients with localized unresectable chemo-resistant tumors is expected to be about 30%.


Secondary Outcome Measures :
  1. Local failure defined as disease recurrence only at the primary site of disease at diagnosis [ Time Frame: Up to 60 months ]
    The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model.

  2. Regional failure defined as disease recurrence at lymph nodes regional to the primary disease site, with or without local failure but without distant failure [ Time Frame: Up to 60 months ]
    The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model.

  3. Distant failure defined as disease recurrence at sites other than the primary site and diagnosis and nodes regional to that site (metastatic disease, whether or not present at diagnosis), with or without loco-regional failure [ Time Frame: Up to 60 months ]
    The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model.

  4. Adverse event profile of the treatments delivered (chemo-radiotherapy; radiotherapy) [ Time Frame: Up to 60 months ]
    Will be characterized using the current Common Terminology Criteria for Adverse Events version.


Other Outcome Measures:
  1. The relative frequency of actionable mutations across the whole cohort and within more common histological subtypes, like synovial sarcoma and malignant peripheral nerve sheath tumors [ Time Frame: Up to 60 months ]
    Descriptive statistical analyses will be estimated.

  2. Frequency with which combinations of actionable mutations are observed in individual tumor types [ Time Frame: Up to 60 months ]
    Descriptive statistical analyses will be estimated.

  3. Rates of actionable mutations on whole genome sequencing [ Time Frame: Up to 60 months ]
    Descriptive and exploratory statistical analyses will be carried out.

  4. Circulating Tumor deoxyribonucleic acid (DNA) [ Time Frame: Up to 60 months ]
    Descriptive analyses will be performed.

  5. Pharmacokinetic parameters of doxorubicin hydrochloride and pazopanib hydrochloride [ Time Frame: Up to 48 hours after the end of infusion ]
    The present trial is designed to allow detection of statistically significant changes in the mean clearance of doxorubicin of at least 25% using a one-sample analysis, which concerns testing an observed experimental mean against the expected (historical) mean of 25.6 L/h/m^2.

  6. Change in fludeoxyglucose F 18 (FDG) positron emission tomography (PET) maximum standard uptake value (SUVmax) [ Time Frame: Baseline to week 13 ]
    The FDG-PET images will be assessed as positive or negative at the primary site and PET response will be descriptively compared to the findings at Week 10 or 13 surgery.

  7. Relative risk of failure based on both standard imaging and pathologic assessment [ Time Frame: Up to 60 months ]
    Log-rank test will be used to see if one response assessment method produces a larger difference in outcome between the response categories.



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:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk will be eligible for the chemotherapy or non-chemotherapy cohort based on:

    • Evidence of chemotherapy sensitivity of the histologic sarcoma subtype based on existing evidence from prior clinical trials
    • Sufficient risk of metastatic disease to warrant chemotherapy based on size and grade and
    • Medically deemed able or unable to undergo chemotherapy
    • Notes: an incisional biopsy or core biopsy is preferred; fine needle aspiration biopsy is not acceptable to establish the diagnosis
  • ELIGIBLE SITES:

    • Extremities: upper (including shoulder) and lower (including hip)
    • Trunk: body wall
  • INELIGIBLE SITES: Head and neck, visceral organs (with the exception of embryonal sarcoma of the liver), retroperitoneum, peritoneum, pelvis within the confines of the bony pelvis
  • ELIGIBILITY FOR CHEMOTHERAPY COHORT:
  • Stage T2a/b (> 5 cm) and grade 2 or 3 AND
  • One of the following chemosensitive histologies as defined in the World Health Organization (WHO) classification of soft tissue tumors (with some evidence of good response to chemoradiation and of sufficient high risk of metastases, or clear evidence of metastases):

    • Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called "undifferentiated soft tissue sarcoma" or "soft tissue sarcoma not otherwise specified [NOS]")
    • Synovial sarcoma
    • Angiosarcoma of soft tissue
    • Adult fibrosarcoma
    • Mesenchymal (extraskeletal) chondrosarcoma
    • Leiomyosarcoma
    • Liposarcoma (excluding myxoid liposarcoma)
    • Undifferentiated pleomorphic sarcoma
    • Embryonal sarcoma of the liver
  • Patients meeting the above criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the chemotherapy cohort or the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort
  • Patients with the following histologies are only eligible for the chemotherapy cohort and cannot enroll on the non-chemotherapy cohort:

    • Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called "undifferentiated soft tissue sarcoma" or "soft tissue sarcoma NOS") in patients < 30 years of age
    • Synovial sarcoma
    • Embryonal sarcoma of the liver
  • ELIGIBILITY FOR NON-CHEMOTHERAPY COHORT:
  • Patients with any size of grade 2 or 3 of the following "intermediate (rarely metastasizing)" or "malignant" tumors, as defined in the WHO classification of soft tissue tumors for which we have consensus data of chemotherapy-resistance are eligible only for the non-chemotherapy cohort:

    • So-called fibrohistiocytic tumors - plexiform fibrohistiocytic tumor, giant cell tumor of soft tissues
    • Fibroblastic/myofibroblastic tumors - solitary fibrous tumor, malignant solitary fibrous tumor, inflammatory myofibroblastic tumor, low grade myofibroblastic sarcoma, myxoinflammatory fibroblastic sarcoma, atypical myxoinflammatory fibroblastic tumor, myxofibrosarcoma, low grade fibromyxoid sarcoma, sclerosing epithelioid fibrosarcoma
    • Tumors of uncertain differentiation - epithelioid sarcoma, alveolar soft part sarcoma, clear cell sarcoma of soft tissue, angiomatoid fibrous histiocytoma, ossifying fibromyxoid tumor, myoepithelioma, myoepithelial carcinoma, extraskeletal myxoid chondrosarcoma, neoplasms with perivascular epithelioid cell differentiation (PEComa), intimal sarcoma, atypical fibroxanthoma, mixed tumor NOS, phosphaturic mesenchymal tumor, malignant ossifying fibromyxoid tumor, malignant mixed tumor, malignant phosphaturic mesenchymal tumor
    • Chondro-osseous tumors - extraskeletal osteosarcoma
    • Pericytic (perivascular) tumors - malignant glomus tumor
    • Nerve sheath tumors - malignant peripheral nerve sheath tumor, malignant granular cell tumor, epithelioid malignant peripheral nerve sheath tumor, malignant Triton tumor
    • Undifferentiated sarcomas (with a specific pathologic category in the WHO classification) - undifferentiated round cell sarcoma, undifferentiated epithelioid sarcoma, undifferentiated spindle cell sarcoma
  • Patients meeting the criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort; note that tumors arising in bone are NOT eligible for this study
  • Extent of disease:

    • Patients with non-metastatic and metastatic disease are eligible
    • Initially unresectable patients, with or without metastatic disease, are eligible as long as there is a commitment at enrollment to resect the primary tumor
  • Sufficient tissue and blood must be available to submit for required biology studies
  • Lansky performance status score >= 70 for patients =< 16 years of age
  • Karnofsky performance status score >= 70 for patients > 16 years of age
  • Absolute neutrophil count >= 1500/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility
  • Platelet count >= 100,000/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility
  • Hemoglobin >= 8 g/dL for patients =< 16 years of age; >= 9 g/dL for patients > 16 years of age; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or normal serum creatinine based on age/gender as follows:

    • 2 to < 6 years; 0.8 mg/dL male; 0.8 mg/dL female
    • 6 to < 10 years; 1 mg/dL male; 1 mg/dL female
    • 10 to < 13 years; 1.2 mg/dL male; 1.2 mg/dL female
    • 13 to < 16 years; 1.5 mg/dL male; 1.4 mg/dL female
    • >= 16 years; 1.5 mg/dL male; 1.4 mg/dL female
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age
  • Shortening fraction of >= 27% by echocardiogram OR ejection fraction of >= 50% by radionuclide angiogram
  • Corrected QT interval (QTc) < 480 msec
  • No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading > 94% on room air if there is clinical indication for determination
  • Patients on low molecular weight heparin or Coumadin (with a stable international normalized ratio [INR]) are eligible
  • Patient must have a life expectancy of at least 3 months with appropriate therapy
  • 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 grade 1 NRSTS tumors of any size are not eligible
  • Patients with known central nervous system (CNS) metastases are not eligible; Note: brain imaging is not an eligibility requirement
  • Patients with evidence of active bleeding or bleeding diathesis will be excluded (Note: patients aged > 17 years with excess of 2.5 mL of hemoptysis are not eligible)
  • Patients with gross total resection of the primary tumor prior to enrollment on ARST1321 are NOT eligible; patients who have experienced tumor recurrence after a gross total tumor resection are NOT eligible
  • Patients with uncontrolled hypertension are ineligible; uncontrolled hypertension is defined as follows:

    • Patients aged =< 17 years: greater than 95th percentile systolic and diastolic blood pressure based on age and height which is not controlled by one anti-hypertensive medication
    • Patients aged > 17 years: systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg that is not controlled by one anti-hypertensive medication
  • Prior Therapy:

    • Patients must have had no prior anthracycline (e.g., doxorubicin, daunorubicin) or ifosfamide chemotherapy
    • Patients must have had no prior use of pazopanib or similar multi-targeted tyrosine kinase inhibitors (TKI)
    • Patients must have had no prior radiotherapy to tumor-involved sites
    • Note: patients previously treated for a non-NRSTS cancer are eligible provided they meet the prior therapy requirements; patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded
  • Other types of invasive malignancy that are not disease free within 3 years except for non-melanoma skin cancer, lentigo maligna, any carcinoma-in-situ or prostate cancer with low risk factors
  • CYTOCHROME P450 3A4 (CYP3A4) substrates WITH narrow therapeutic indices: patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices within 7 days prior to study enrollment, including but not limited to pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; Note: the use of fentanyl is permitted
  • CYP3A4 Inhibitors: patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to itraconazole, clarithromycin, erythromycin many non-nucleoside reverse-transcriptase inhibitors (NNRTIs), diltiazem, verapamil, and grapefruit juice are not eligible
  • CYP3A4 Inducers: patients chronically receiving drugs that are known potent CYP3A4 inducers within 14 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampin, and St. John's wort are not eligible (with the exception of glucocorticoids)
  • Certain medications that are associated with a risk for QTc prolongation and/or Torsades de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible
  • Subjects with any condition that may impair the ability to swallow or absorb oral medications/investigational product including:

    • Any lesion, whether induced by tumor, radiation or other conditions, which makes it difficult to swallow capsules or pills
    • Prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel
    • Active peptic ulcer disease
    • Malabsorption syndrome
  • Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:

    • Active peptic ulcer disease
    • Known intraluminal metastatic lesions
    • Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation
    • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to beginning study treatment
  • Subjects with any of the following cardiovascular conditions within the past 6 months

    • Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
    • Cardiac arrhythmia
    • Admission for unstable angina
    • Cardiac angioplasty or stenting
    • Coronary artery bypass graft surgery
    • Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks
    • Arterial thrombosis
    • Symptomatic peripheral vascular disease
    • Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible
  • History of serious or non-healing wound, ulcer, or bone fracture
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients who are unable to swallow whole tablets are not eligible
  • Patients with a body surface area < 0.5 m^2 are not eligible
  • Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible
  • Patients who are receiving any other investigational agent(s)
  • Pregnancy and breast feeding:

    • Female patients who are pregnant are ineligible
    • Lactating females are not eligible unless they have agreed not to breastfeed their infants during treatment and for a period of 1 month following completion of treatment
    • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
  • Unwillingness to use an effective contraceptive method for the duration of their study participation and for at least 1 month after treatment is completed if sexually active with reproductive potential

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): NCT02180867


  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States, 35243
United States, Alaska
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States, 98508
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, United States, 99508
Anchorage Oncology Centre
Anchorage, Alaska, United States, 99508
Katmai Oncology Group
Anchorage, Alaska, United States, 99508
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Cardon Children's Medical Center
Mesa, Arizona, United States, 85202
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States, 85724
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
United States, California
Kaiser Permanente-Anaheim
Anaheim, California, United States, 92806
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States, 93301
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
Kaiser Permanente Downey Medical Center
Downey, California, United States, 90242
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States, 90806
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Valley Children's Hospital
Madera, California, United States, 93636
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609-1809
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Children's Hospital of Orange County
Orange, California, United States, 92868
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Kaiser Permanente-Riverside
Riverside, California, United States, 92505
Sutter Medical Center Sacramento
Sacramento, California, United States, 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Kaiser Permanente-San Diego Zion
San Diego, California, United States, 92120
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Kaiser Permanente-San Marcos
San Marcos, California, United States, 92078
Kaiser San Rafael-Gallinas
San Rafael, California, United States, 94903
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States, 96161
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
University of Colorado Hospital
Aurora, Colorado, United States, 80045
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States, 80909
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States, 80218
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Yale University
New Haven, Connecticut, United States, 06520
United States, Delaware
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
MedStar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States, 32610
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Florida Hospital Orlando
Orlando, Florida, United States, 32803
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, United States, 33701
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States, 33607
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Saint Mary's Hospital
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States, 30322
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
United States, Hawaii
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States, 96819
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
United States, Idaho
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States, 83619
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States, 83642
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, United States, 83686
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States, 83301
United States, Illinois
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Illinois
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States, 60453
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, United States, 60068
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Saint John's Hospital
Springfield, Illinois, United States, 62702
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Memorial Medical Center
Springfield, Illinois, United States, 62781
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
Reid Health
Richmond, Indiana, United States, 47374
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Broadlawns Medical Center
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
United States, Kansas
Newman Regional Health
Emporia, Kansas, United States, 66801
Central Care Cancer Center - Garden City
Garden City, Kansas, United States, 67846
Saint Catherine Hospital
Garden City, Kansas, United States, 67846
Central Care Cancer Center - Great Bend
Great Bend, Kansas, United States, 67530
Saint Rose Ambulatory and Surgery Center
Great Bend, Kansas, United States, 67530
Hays Medical Center
Hays, Kansas, United States, 67601
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Olathe Medical Center
Olathe, Kansas, United States, 66061
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States, 66762
Salina Regional Health Center
Salina, Kansas, United States, 67401
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States, 66606
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
United States, Kentucky
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, United States, 40202
Norton Suburban Hospital and Medical Campus
Louisville, Kentucky, United States, 40207
United States, Louisiana
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Henry Ford Cancer Institute¿Downriver
Brownstown, Michigan, United States, 48183
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States, 48038
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Ascension Saint John Hospital
Detroit, Michigan, United States, 48236
Michigan State University Clinical Center
East Lansing, Michigan, United States, 48824-7016
Hurley Medical Center
Flint, Michigan, United States, 48503
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Allegiance Health
Jackson, Michigan, United States, 49201
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49048
Sparrow Hospital
Lansing, Michigan, United States, 48912
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Lakeland Hospital Niles
Niles, Michigan, United States, 49120
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
Beaumont Children's Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States, 48322
United States, Minnesota
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States, 65613
Columbia Regional
Columbia, Missouri, United States, 65201
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Freeman Health System
Joplin, Missouri, United States, 64804
The Childrens Mercy Hospital
Kansas City, Missouri, United States, 64108
The University of Kansas Cancer Center-South
Kansas City, Missouri, United States, 64131
Research Medical Center
Kansas City, Missouri, United States, 64132
The University of Kansas Cancer Center-North
Kansas City, Missouri, United States, 64154
The University of Kansas Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States, 64064
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States, 65401
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, United States, 63104
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Nebraska
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, United States, 89106
21st Century Oncology
Las Vegas, Nevada, United States, 89109
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States, 89135
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States, 89144
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Saint Mary's Regional Medical Center
Reno, Nevada, United States, 89503
Radiation Oncology Associates
Reno, Nevada, United States, 89509
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Montefiore Medical Center-Einstein Campus
Bronx, New York, United States, 10461
Montefiore Medical Center-Weiler Hospital
Bronx, New York, United States, 10461
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Glens Falls Hospital
Glens Falls, New York, United States, 12801
NYU Winthrop Hospital
Mineola, New York, United States, 11501
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Mount Sinai Hospital
New York, New York, United States, 10029
Columbia University/Herbert Irving Cancer Center
New York, New York, United States, 10032
Weill Medical College of Cornell University
New York, New York, United States, 10065
University of Rochester
Rochester, New York, United States, 14642
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Mission Hospital Inc-Memorial Campus
Asheville, North Carolina, United States, 28801
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina University
Greenville, North Carolina, United States, 27834
Matthews Radiation Oncology Center
Matthews, North Carolina, United States, 28105
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States, 44122
Indu and Raj Soin Medical Center
Beavercreek, Ohio, United States, 45431
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, United States, 45459
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, United States, 45236
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, United States, 45242
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Dayton Physicians LLC-Samaritan North
Dayton, Ohio, United States, 45415
Miami Valley Hospital North
Dayton, Ohio, United States, 45415
Armes Family Cancer Center
Findlay, Ohio, United States, 45840
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Orion Cancer Care
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Dayton Physicians LLC-Atrium
Franklin, Ohio, United States, 45005
Dayton Physicians LLC-Wayne
Greenville, Ohio, United States, 45331
Wayne Hospital
Greenville, Ohio, United States, 45331
Greater Dayton Cancer Center
Kettering, Ohio, United States, 45409
Kettering Medical Center
Kettering, Ohio, United States, 45429
Springfield Regional Cancer Center
Springfield, Ohio, United States, 45504
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Dayton Physicians LLC-Upper Valley
Troy, Ohio, United States, 45373
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States, 73120
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Saint Charles Health System
Bend, Oregon, United States, 97701
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Bay Area Hospital
Coos Bay, Oregon, United States, 97420
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States, 18017
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033
Drexel University School of Medicine
Philadelphia, Pennsylvania, United States, 19102
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Palmetto Health Richland
Columbia, South Carolina, United States, 29203
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States, 29601
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Saint Francis Cancer Center
Greenville, South Carolina, United States, 29607
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
T C Thompson Children's Hospital
Chattanooga, Tennessee, United States, 37403
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States, 37203
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
El Paso Children's Hospital
El Paso, Texas, United States, 79905
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
University Medical Center
Lubbock, Texas, United States, 79415
Texas Tech University Health Sciences Center-Lubbock
Lubbock, Texas, United States, 79430
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
South Jordan Health Center
South Jordan, Utah, United States, 84009
United States, Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont, United States, 05602
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
University of Vermont College of Medicine
Burlington, Vermont, United States, 05405
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
Carilion Clinic Children's Hospital
Roanoke, Virginia, United States, 24014
United States, Washington
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, United States, 98520
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Providence Regional Cancer System-Centralia
Centralia, Washington, United States, 98531
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336
Providence Regional Cancer System-Lacey
Lacey, Washington, United States, 98503
PeaceHealth Saint John Medical Center
Longview, Washington, United States, 98632
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States, 98107
Kaiser Permanente Washington
Seattle, Washington, United States, 98112
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, West Virginia
West Virginia University Charleston Division
Charleston, West Virginia, United States, 25304
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States, 53105
Aurora Health Center-Fond du Lac
Fond Du Lac, Wisconsin, United States, 54937
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States, 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States, 53024
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States, 53142
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, United States, 54143
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States, 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53233
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
Aurora Cancer Care-Racine
Racine, Wisconsin, United States, 53406
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States, 53081
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States, 54241
Aurora Cancer Care-Waukesha
Waukesha, Wisconsin, United States, 53188
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States, 53226
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Child Health Centre
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Children's Hospital
London, Ontario, Canada, N6A 5W9
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H3H 1P3
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Canada
Centre Hospitalier Universitaire de Quebec
Quebec, Canada, G1V 4G2
Puerto Rico
San Jorge Children's Hospital
San Juan, Puerto Rico, 00912
University Pediatric Hospital
San Juan, Puerto Rico, 00926
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Aaron Weiss Children's Oncology Group

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02180867     History of Changes
Other Study ID Numbers: NCI-2014-01340
NCI-2014-01340 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
s14-02023
ARST1321
ARST1321 ( Other Identifier: Childrens Oncology Group )
ARST1321 ( Other Identifier: CTEP )
U10CA180830 ( U.S. NIH Grant/Contract )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Neoplasms
Sarcoma
Osteosarcoma
Leiomyosarcoma
Liposarcoma
Chondrosarcoma
Sarcoma, Synovial
Fibrosarcoma
Nerve Sheath Neoplasms
Histiocytoma
Sarcoma, Alveolar Soft Part
Neurilemmoma
Neurofibrosarcoma
Histiocytoma, Benign Fibrous
Sarcoma, Clear Cell
Granuloma, Plasma Cell
Histiocytoma, Malignant Fibrous
Chondrosarcoma, Mesenchymal
Skin Neoplasms
Glomus Tumor
Granular Cell Tumor
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Muscle Tissue
Neoplasms, Adipose Tissue
Neoplasms, Fibrous Tissue
Neoplasms, Nerve Tissue
Peripheral Nervous System Neoplasms