drugset / Trial / NCT01055314
Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-01
- Primary completion
- 2016-06
- Completion
- 2016-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cixutumumab | Monoclonal antibody | — | Intravenous |
| Subject | Temozolomide | Small molecule | — | Oral |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Dactinomycin | Protein / enzyme biologic | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |
| Background | Etoposide | Small molecule | — | Intravenous |
| Background | Ifosfamide | Small molecule | — | Intravenous |
| Background | Irinotecan | Small molecule | — | Intravenous |
| Background | Vincristine | Small molecule | — | Intravenous |