Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma

NCT00025363 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2013-01-17

No results posted yet for this study

Summary

Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have rhabdomyosarcoma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells

Conditions

  • Alveolar Childhood Rhabdomyosarcoma
  • Embryonal Childhood Rhabdomyosarcoma
  • Embryonal-botryoid Childhood Rhabdomyosarcoma
  • Previously Treated Childhood Rhabdomyosarcoma
  • Recurrent Childhood Rhabdomyosarcoma

Interventions

DRUG

vincristine sulfate

Given IV

DRUG

irinotecan hydrochloride

Given IV

DRUG

cyclophosphamide

Given IV

DRUG

doxorubicin hydrochloride

Given IV

DRUG

ifosfamide

Given IV

DRUG

etoposide

Given IV

DRUG

tirapazamine

Given IV

BIOLOGICAL

filgrastim

Given SC

BIOLOGICAL

sargramostim

Given SC

OTHER

pharmacological study

Correlative studies

OTHER

pharmacogenomic studies

Correlative studies

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Philip Breitfeld · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2007-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00025363 on ClinicalTrials.gov