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

Running, not enrolling · Phase 3

Conditions studied: 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

In brief

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. Treatment with drugs that block the IGF-1R pathway, such as ganitumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as vincristine, doxorubicin, 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 adding ganitumab to combination chemotherapy is more effective in treating patients with newly diagnosed metastatic Ewing sarcoma.

Key facts

Study ID

NCT02306161

Run by

National Cancer Institute (NCI)

People needed

312

Starts

2014-12-12

Expected to finish

2026-09-17

Last updated by the study team

2026-07-29

Who can join

Age: any, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (performed within 7 days prior to enrollment):
• 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 (performed within 7 days prior to enrollment), and
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment) (except for patients with liver metastasis who may enroll if ALT < 5 times ULN for age)

You may not qualify if…

• 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 (e.g. 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

Where it is running

• USA Health Strada Patient Care Center — Mobile, Alabama, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Banner Children's at Desert — Mesa, Arizona, United States
• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• Onvida Health Yuma Medical Center — Yuma, Arizona, United States
• CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Kaiser Permanente Downey Medical Center — Downey, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• UCSF Medical Center-Mission Bay — San Francisco, California, United States
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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