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Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma

NCT00077285 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-05-22

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin as upfront window therapy (first-line therapy) works in treating patients with newly diagnosed intermediate-risk or high-risk rhabdomyosarcoma.

Conditions

  • Sarcoma

Interventions

BIOLOGICAL

filgrastim

DRUG

carboplatin

DRUG

cyclophosphamide

DRUG

dexrazoxane hydrochloride

DRUG

doxorubicin hydrochloride

DRUG

etoposide

DRUG

ifosfamide

DRUG

irinotecan hydrochloride

DRUG

vincristine sulfate

PROCEDURE

conventional surgery

RADIATION

radiation therapy

Sponsors & Collaborators

Principal Investigators

  • Leonard H. Wexler, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00077285 on ClinicalTrials.gov