Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma

Conditions

• Adult Rhabdomyosarcoma
• Childhood Alveolar Rhabdomyosarcoma
• Childhood Embryonal Rhabdomyosarcoma
• Metastatic Childhood Soft Tissue Sarcoma
• Stage IV Adult Soft Tissue Sarcoma
• Untreated Childhood Rhabdomyosarcoma

Eligibility Criteria

Sex

ALL

Age

N/A - 49 Years

Healthy Volunteers

Not accepted

Interventions

• Cixutumumab — BIOLOGICAL
  Given IV
• Cyclophosphamide — DRUG
  Given IV
• Dactinomycin — BIOLOGICAL
  Given IV
• Doxorubicin Hydrochloride — DRUG
  Given IV
• Etoposide — DRUG
  Given IV
• Ifosfamide — DRUG
  Given IV
• Irinotecan Hydrochloride — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Temozolomide — DRUG
  Given PO
• Vincristine Sulfate Liposome — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Jan 31, 2010

Status verified

Jul 2017

Primary completion

Jun 30, 2016

Completion

Jun 30, 2016

Study Design

Enrollment

175 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1 (chemotherapy, radiation therapy, cixutumumab)
  Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-5, 7, 8, 11, 12, 15, 16, 20-24, 28, 29, 32, 33, 35, 38, 41-44, 47, 48, 50, and 51; irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 1, 4, 20, 23, 47, and 50; ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 of weeks 9, 13, 17, 26, and 30; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 7, 11, 15, 28, and 32; cyclophosphamide IV over 30-60 minutes on day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41, and 44; dactinomycin IV over 1-5 minutes on day 1 of weeks 35, 38, 41, and 44; and cixutumumab IV over 1 hour on day 1 of weeks 1-51. Patients also undergo radiation therapy on days 1-5 of weeks 20-24.
• Experimental: Group 2 (chemotherapy, radiation therapy, temozolomide)
  Patients receive vincristine sulfate, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin and undergo radiation therapy as in group 1. Patients also receive temozolomide PO on days 1-5 of weeks 1, 4, 20, 23, 47, and 50.

Primary Outcome Measure

Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment [ Time Frame: From start to week 26 of therapy ]

Locations (121)

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