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

Alternate Title

Phase I/II Study of High-Dose Methotrexate, Glucarpidase, and Leucovorin Calcium Rescue in Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Biomarker/Laboratory analysis, Supportive care, Treatment	Active	18 and over	Other	CRUK-BRD/07/004 CRUK-BRD/07/004, 2007-002570-58, EU-20861, NCT00727831

Trial Description

Purpose:

Drugs used in chemotherapy, such as methotrexate and leucovorin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Glucarpidase may help return the level of methotrexate in the blood to a safe range. Giving high-dose methotrexate together with glucarpidase and leucovorin may kill more cancer cells.

This phase I/II trial is studying the side effects and best dose of methotrexate when given together with glucarpidase and leucovorin in treating patients with newly diagnosed primary central nervous system lymphoma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• 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 4-hour infusion of methotrexate on day 1. They will also receive an infusion of glucarpidase on day 2 and leucovorin by mouth or by infusion on days 2-7. Treatment may repeat every 2 weeks for up to six courses.

Beginning 2-4 weeks later, some patients may undergo whole-brain radiation therapy 5 days a week for up to 5 weeks.

Patients will undergo blood sample collection periodically for laboratory studies.

Patients will fill out quality-of-life questionnaires before, during, and after the study. After finishing treatment, they will be evaluated at 6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months 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

Cancer Research UK Clinical Centre at St. James's University Hospital

Roderick Johnson, MD, Principal investigator		Ph: 44-113-392-3766

United Kingdom
England
	Leeds
	Leeds General Infirmary
		Roderick Johnson, MD	Ph:  44-113-392-3766
	Torquay
	Torbay Hospital
		Deborah Turner	Ph:  44-180-365-5244
			Email: deborah.turner2@nhs.net

Registry Information
Official Title		Phase I Trial of Escalating High Dose Methotrexate Supported by Glucarpidase to Treat Patients With Primary Central Nervous Lymphoma (PCNSL)
Trial Start Date		2008-07-01
Trial Completion Date		2010-07-01 (estimated)
Registered in ClinicalTrials.gov		NCT00727831
Date Submitted to PDQ		2008-06-20
Information Last Verified		2008-11-30