At a glance
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A Pilot Study to Evaluate Novel Agents (Temozolomide and Cixutumumab [IMC-A12, Anti-IGF-IR Monoclonal Antibody NSC # 742460]) in Combination With Intensive Multi-agent Interval Compressed Therapy for Patients With High-Risk Rhabdomyosarcoma
In Brief
A Phase 2 clinical trial evaluating Cixutumumab, Cyclophosphamide, and 8 other interventions for Adult Rhabdomyosarcoma and 5 related conditions. Completed, enrolled 175 participants across 139 sites in 4 countries.
Detailed Summary
This randomized pilot clinical trial is studying the side effects and how well giving temozolomide and cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide and cixutumumab together with combination chemotherapy may kill more tumor cells.
Study Details
Timeline
Interventions
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Correlative studies
Given PO
Given IV