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

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.

Conditions

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

Interventions

BIOLOGICAL

Cixutumumab

Given IV

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Dactinomycin

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

DRUG

Ifosfamide

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Temozolomide

Given PO

DRUG

Vincristine Sulfate Liposome

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Suman Malempati, MD · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

49 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2016-06-30

Completion

2016-06-30

Countries

• United States
• Australia
• Canada
• New Zealand

Study Locations