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

Summary

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.

Timeline

Start

2014-12-12

Primary completion

2021-03-31

Completion

2027-09-16

Outcome

Missed primary endpoint

paper Ganitumab added to interval-compressed chemotherapy did not significantly reduce the risk of EFS event PMID 36669140 ↗

paper stratified EFS-event hazard ratio for experimental arm 1.00; 95% CI, 0.76 to 1.33; 1-sided, P = .50 PMID 36669140 ↗

Publications

• von Kruchten R, DelRocco NJ, Adams LC, Singh SB, Varniab ZS, Bender JG, Krailo MD, DuBois S, Daldrup-Link HE. Role of diffusion-weighted MRI in assessing Ewing sarcoma treatment response: Findings from a COG phase III trial. Magn Reson Imaging. 2026 Oct;132:110706. doi: 10.1016/j.mri.2026.110706. Epub 2026 May 27.
• DuBois SG, Krailo MD, Glade-Bender J, Buxton A, Laack N, Randall RL, Chen HX, Seibel NL, Boron M, Terezakis S, Hill-Kayser C, Hayes A, Reid JM, Teot L, Rakheja D, Womer R, Arndt C, Lessnick SL, Crompton BD, Kolb EA, Daldrup-Link H, Eutsler E, Reed DR, Janeway KA, Gorlick RG. Randomized Phase III Trial of Ganitumab With Interval-Compressed Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma: A Report From the Children's Oncology Group. J Clin Oncol. 2023 Apr 10;41(11):2098-2107. doi: 10.1200/JCO.22.01815. Epub 2023 Jan 20.

Drugs

Indications