Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (NCT02306161)

🧪 Interventions in This Study

• Cyclophosphamide (DRUG)
• Doxorubicin (DRUG)
• Doxorubicin Hydrochloride (DRUG)
• Etoposide (DRUG)
• Etoposide Phosphate (DRUG)
• Ganitumab (BIOLOGICAL)
• Ifosfamide (DRUG)
• Vincristine (DRUG)
• Vincristine Sulfate (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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
2. For the purpose of this study metastatic disease is defined as one or more of the following:
3. 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
4. Contralateral pleural effusion and/or contralateral pleural nodules
5. Distant lymph node involvement
6. Patients with pulmonary nodules are considered to have metastatic disease if the patient has:
7. Solitary nodule \>= 0.5 cm or multiple nodules of \>= 0.3 cm unless lesion is biopsied and negative for tumor
8. Patients with solitary nodule \< 0.5 cm or multiple nodules \< 0.3 cm are not considered to have lung metastasis unless biopsy documents tumor
9. 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
10. 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)
11. 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
12. Patients must have adequate tumor tissue to meet the minimum requirement for submission

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (314 Sites)

Showing the first 25 of 314 sites.

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

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Metastatic Ewing Sarcoma

• Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes — Birmingham, Alabama

Explore by condition: All Metastatic Ewing Sarcoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.