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

Alternate Title

Phase I Study of Pemetrexed Disodium in Children and Adolescents With Recurrent Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	1 to 21	NCI	COG-ADVL0311 ADVL0311, NCI-04-C-0261, NCT00070473

Trial Description

Purpose:

Drugs used in chemotherapy, such as pemetrexed disodium, use different ways to stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

This phase I trial is studying the side effects and best dose of pemetrexed disodium in treating young patients with recurrent solid tumors.

Eligibility:

Eligibility criteria include the following:

• 1-21 years old
• At least 1 week since biological therapy
• At least 6 months since allogeneic stem cell transplantation
• No previous pemetrexed disodium
• At least 6 months since radiation therapy to the head and spine
• 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 an infusion of pemetrexed disodium every 3 weeks. Treatment may be repeated for as long as benefit is shown.

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

Children's Oncology Group

H. Stacy Nicholson, MD, MPH, Protocol chair		Ph: 503-494-4265; 800-494-1234 Email: nicholss@ohsu.edu
Linda Stork, MD, Protocol co-chair		Ph: 503-494-1543

Registry Information
Official Title		A Phase I Study of Pemetrexed (LY231514, Alimta) in Children and Adolescents with Recurrent Solid Tumors
Trial Start Date		2003-10-17
Registered in ClinicalTrials.gov		NCT00070473
Date Submitted to PDQ		2003-08-29
Information Last Verified		2006-07-03
NCI Grant/Contract Number		CA97452

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