Chemotherapy +/− Ganitumab for Ewing Sarcoma

Recruiting at 350 trial locations

Overseen by Steven G DuBois

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Steven G DuBois

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for patients with newly diagnosed Ewing sarcoma that has spread, who haven't had prior chemotherapy or radiation. They must have a biopsy of the primary tumor and meet specific health criteria like normal kidney function, heart function, blood sugar levels, and liver enzymes. Pregnant or breastfeeding women are excluded, as well as those with diabetes or on long-term steroids.

Inclusion Criteria

My liver enzyme levels are within the normal range, except I have liver cancer.

My cancer has spread to my bones.

Submission of pre-treatment serum, tumor tissue, and whole blood required

Exclusion Criteria

My cancer started in the soft tissues within the brain's protective layers.

I have had chemotherapy or radiation therapy before.

Lactating females unless they agree not to breastfeed

Treatment Details

Interventions

• Cyclophosphamide (Alkylating agents)
• Doxorubicin (Anti-tumor antibiotic)
• Doxorubicin Hydrochloride (Anti-tumor antibiotic)
• Etoposide (Topoisomerase I inhibitors)
• Etoposide Phosphate (Topoisomerase I inhibitors)
• External Beam Radiation Therapy (Radiation Therapy)
• Ganitumab (Monoclonal Antibodies)
• Ifosfamide (Alkylating agents)
• Quality-of-Life Assessment (Other)
• Stereotactic Radiosurgery (Radiation Therapy)
• Therapeutic Surgical Procedure (Other)
• Vincristine (Vinca alkaloids)
• Vincristine Sulfate (Vinca alkaloids)

Trial Overview The study is testing if adding ganitumab to standard combination chemotherapy (vincristine, doxorubicin, cyclophosphamide, ifosfamide, etoposide) improves outcomes in metastatic Ewing sarcoma. Ganitumab targets the IGF-1R pathway which may help stop cancer growth. Patients are randomly assigned to receive either just chemo or chemo plus ganitumab.

Participant Groups

Group I: Regimen B (VDC/IE + ganitumab) Experimental Treatment 12 Interventions

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 receive 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 whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles.

Group II: Regimen A (VDC/IE) Experimental Treatment 11 Interventions

See Design Details.

Cyclophosphamide is already approved in Canada, Japan for the following indications:

Approved in Canada as Neosar for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Japan as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+