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

Alternate Title

Phase II Study of Rituximab in Combination With Standard Chemotherapy Comprising Methotrexate, Vincristine, Procarbazine Hydrochloride, and Cytarabine in Patients With Primary Central Nervous System Lymphoma

Basic Trial Information

Trial Description

Purpose:

Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.

This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• No systemic lymphoma
• No previous chemotherapy or radiation therapy for primary CNS lymphoma
• No previous organ transplant or bone marrow transplant
• 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 rituximab three times a week in weeks 1-4. They will also receive a 2-hour infusion of methotrexate, followed by leucovorin by mouth or by infusion every 6 hours for 12 doses, and an infusion of vincristine in weeks 1, 3, 5, 7, and 9. Patients will also receive procarbazine by mouth once a day for 1 week in weeks 1, 5, and 9; dexamethasone by mouth once a day in weeks 1-6; and a 2-hour infusion of cytarabine twice a week in weeks 11 and 14. Some patients will also receive intrathecal methotrexate followed by leucovorin by mouth every 12 hours for eight doses in weeks 2, 4, 6, 8, and 10.

After finishing treatment, patients will be evaluated periodically for 5 years.

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

Eastern Cooperative Oncology Group

Lode Swinnen, MD, Protocol chair		Ph: 410-614-3698
Deborah Blumenthal, MD, Protocol co-chair		Ph: 801-585-0211; 877-585-0303 Email: deborah.blumenthal@hsc.utah.edu

Registry Information
Official Title		Phase II Study of Rituximab Given in Conjunction with Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma
Trial Start Date		2006-12-21
Trial Completion Date		2011-10-15 (estimated)
Registered in ClinicalTrials.gov		NCT00335140
Date Submitted to PDQ		2006-03-07
Information Last Verified		2010-02-25
NCI Grant/Contract Number		CA21115

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