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

Alternate Title

Phase III Randomized Study of Pegasparaginase Verus E. coli Asparaginase With Combination Chemotherapy in Children With Newly Diagnosed Acute Lymphoblastic Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	1 to 17	NCI	DFCI-05001 NCT00400946

Trial Description

Purpose:

Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known whether pegasparaginase is more effective than asparaginase when given together with combination chemotherapy in treating acute lymphoblastic leukemia.

This randomized phase III trial is studying pegasparaginase to see how well it works compared with asparaginase when given together with combination chemotherapy in treating young patients with newly diagnosed acute lymphoblastic leukemia.

Eligibility:

Eligibility criteria include the following:

• 1-17 years old
• No acute lymphoblastic leukemia that developed after treatment for another cancer or condition
• No previous treatment other than steroids and/or radiation therapy to the chest
• 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 combination chemotherapy intrathecally, by infusion, by mouth, and by injection for up to approximately 2 years. They will be randomized to receive pegasparaginase or asparaginase. Some patients will also undergo radiation therapy to the head once a day for 8 or 10 days.

Patients will fill out questionnaires about their diet on the day of diagnosis, in week 5, and at 1 year. Quality of life will be assessed periodically. After finishing treatment, patients will be evaluated periodically for 3 years 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

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Lewis Silverman, MD, Principal investigator		Ph: 617-632-6191; 866-790-4500

U.S.A.
Massachusetts
	Boston
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		Lewis Silverman, MD	Ph:  617-632-6191 866-790-4500
New York
	Bronx
	Albert Einstein Cancer Center at Albert Einstein College of Medicine
		Clinical Trials Office - Albert Einstein Cancer Center at Albert Einstein College of Medicine	Ph:  718-904-2730
			Email: aecc@aecom.yu.edu
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	Ph:  212-305-8615
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Barbara Asselin, MD	Ph:  716-275-2981
Rhode Island
	Providence
	Hasbro Children's Hospital
		Clinical Trials Office - Hasbro Children's Hospital	Ph:  401-444-8945
Virginia
	Fairfax
	INOVA Fairfax Hospital
		Marshall Schorin, MD	Ph:  703-750-8800
Canada
Ontario
	Hamilton
	McMaster Children's Hospital at Hamilton Health Sciences
		Uma Athale, MD	Ph:  905-521-2000 ext. 73464
Quebec
	Montreal
	Hopital Sainte Justine
		Albert Moghrabi, MD	Ph:  514-345-4969
			Email: albert.moghrabi@umontreal.ca
	Sainte Foy
	Centre de Recherche du Centre Hospitalier de l'Universite Laval
		Bruno Michon, MD	Ph:  418-656-4141
Puerto Rico
	Santurce
	San Jorge Children's Hospital
		Luis Clavell, MD	Ph:  787-726-0316
			Email: luis.clavell@sjcms.com

Registry Information
Official Title		Treatment of Acute Lymphoblastic Leukemia in Children
Trial Start Date		2005-04-22
Trial Completion Date		2010-05-03 (estimated)
Registered in ClinicalTrials.gov		NCT00400946
Date Submitted to PDQ		2006-10-04
Information Last Verified		2009-06-07
NCI Grant/Contract Number		CA068484, CA06516

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