Clinical Trial Title Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
Trial Status Closed to Enrollment
Start Date 03/17/2010
Location randall-childrens-hospital-at-legacy-emanuel
Trial Type Pediatric Cancer (Oncology)
Specific Condition Rhabdomyosarcoma (High Risk)
Description 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.
Eligibility Criteria Patients must be eligible for and enrolled on D9902 prior to enrollment on ARST08P1

Age for embryonal RMS: Age > 10 years and < 50 years at the time of enrollment

Age for alveolar RMS or ectomesenchymoma: Age <50 years at the time of enrollment

Patients with newly diagnosed, biopsy proven metastatic rhabdomyosarcoma or
ectomesenchymoma (Stage IV, Clinical Group IV) are eligible for this study

No prior chemotherapy or radiation therapy except for use of corticosteroids or emergent radiation therapy

Adequate kidney, liver, heart, and hematological (blood counts) functions
IRB Number

Study status is:
Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).
Principal Investigator Janice Olson, MD
Contact Name Children's Cancer and Blood Disorders Program
Contact Phone (503) 276-9300
Contact Fax
Contact E-Mail