Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma

Summary

This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well each works in treating patients with previously untreated rhabdomyosarcoma or sarcoma. Drugs used in chemotherapy, such as dactinomycin, cyclophosphamide, vincristine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma.

Conditions

• Adult Malignant Mesenchymoma
• Adult Rhabdomyosarcoma
• Alveolar Childhood Rhabdomyosarcoma
• Childhood Malignant Mesenchymoma
• Embryonal Childhood Rhabdomyosarcoma
• Embryonal-botryoid Childhood Rhabdomyosarcoma
• Nonmetastatic Childhood Soft Tissue Sarcoma
• Previously Untreated Childhood Rhabdomyosarcoma
• Stage I Adult Soft Tissue Sarcoma
• Stage II Adult Soft Tissue Sarcoma
• Stage III Adult Soft Tissue Sarcoma

Interventions

BIOLOGICAL

dactinomycin

Given IV

DRUG

vincristine sulfate

Given IV

DRUG

cyclophosphamide

Given IV

PROCEDURE

therapeutic conventional surgery

Undergo surgery

RADIATION

radiation therapy

Undergo radiotherapy

DRUG

topotecan hydrochloride

Given IV

BIOLOGICAL

filgrastim

Given SC

BIOLOGICAL

sargramostim

Given SC

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Carola Arndt · 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

2002-09-30

Primary Completion

2007-10-31

Countries

• United States

Study Locations