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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Pilot Study of Irinotecan and Carboplatin as Upfront Window Therapy in Patients With Newly Diagnosed Intermediate- or High-Risk Rhabdomyosarcoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	30 and under at diagnosis	NCI	MSKCC-03099 NCT00077285

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• Younger than 31 at diagnosis
• No more than 6 weeks since surgery or biopsy
• No previous chemotherapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive a 1-hour infusion of carboplatin on day 1 and a 1-hour infusion of irinotecan 5 days a week for 2 weeks. Treatment may be repeated every 3 weeks for two courses.

Patients will then receive infusions of combination chemotherapy and injections of filgrastim for up to 1 year. Patients will also undergo radiation therapy for up to 5.5 weeks. Some patients may undergo surgery to remove the tumor.

Patients will be evaluated once a month for 1 year, every 3 months for 1 year, every 6 months for 1 year, and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Leonard Wexler, MD, Protocol chair		Ph: 212-639-7990; 800-525-2225 Email: wexlerl@mskcc.org

U.S.A.
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Leonard Wexler, MD	Ph:  212-639-7990 800-525-2225
			Email: wexlerl@mskcc.org
		Paul Meyers, MD	Ph:  212-639-5952 800-525-2225
			Email: meyersp@mskcc.org

Registry Information
Official Title		A Pilot Phase II Trial Of Irinotecan Plus Carboplatin, And Irinotecan Maintenance Therapy (High-Risk Patients Only), Integrated Into The Upfront Therapy Of Newly Diagnosed Patients With Intermediate - And High-Risk Rhabdomyosarcoma
Trial Start Date		2003-10-28
Trial Completion Date		2010-10-28 (estimated)
Registered in ClinicalTrials.gov		NCT00077285
Date Submitted to PDQ		2003-12-16
Information Last Verified		2009-07-05
NCI Grant/Contract Number		P30-CA08748

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