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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 Rituximab in Combination With Blood-Brain Barrier Disruption With Mannitol, Combination Chemotherapy Comprising Methotrexate and Carboplatin, and Delayed Sodium Thiosulfate in Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	18 to 75	NCI	OHSU-1012 OHSU-SOL-05025-L, NCT00293475

Trial Description

Purpose:

Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as methotrexate, carboplatin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as sodium thiosulfate, may protect normal cells from the side effects of chemotherapy. Osmotic blood-brain barrier disruption uses certain drugs, such as mannitol, to open the blood vessels around the brain and allow methotrexate and carboplatin to be carried directly to the brain. Giving rituximab together with mannitol and combination chemotherapy may kill more cancer cells.

This phase I/II trial is studying the side effects and best dose of carboplatin when given together with rituximab, mannitol, methotrexate, and sodium thiosulfate and to see how well they work in treating patients with newly diagnosed primary central nervous system lymphoma.

Eligibility:

Eligibility criteria include the following:

• 18-75 years old
• At least 4 weeks since chemotherapy
• At least 10 days since methotrexate
• No previous radiation therapy to the brain or 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 a 5-hour infusion of rituximab on day 1. On days 2 and 3, they will receive infusions of mannitol, methotrexate, and carboplatin into an artery that goes to the brain. Patients will also receive an infusion of sodium thiosulfate twice a day on days 2 and 3. Beginning on day 5, they will receive either an injection of G-CSF once a day for approximately 7-10 days or until blood counts return to normal or they will receive a single injection of pegfilgrastim. Some patients will also receive an infusion of cytarabine by Ommaya reservoir or by lumbar puncture in week 2. Some patients may also receive injections of methotrexate into the eye periodically for up to 1 year.

Quality of life will be assessed before beginning treatment, every 6 months during treatment, after finishing treatment, and then every 3 months for 2 years, 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

Knight Cancer Institute at Oregon Health and Science University

Edward Neuwelt, MD, Protocol chair		Ph: 503-494-5626; 800-494-1234 Email: Neuwelte@ohsu.edu

U.S.A.
Ohio
	Cincinnati
	Good Samaritan Hospital Cancer Treatment Center
		Robert Albright, MD	Ph:  513-936-5370
			Email: ralbright@ohcmail.com
	Cleveland
	Cleveland Clinic Cancer Center at Fairview Hospital
		Clinical Trials Office - Cleveland Clinic Cancer Center at Fairview Hospital	Ph:  216-476-9362
Oregon
	Portland
	Knight Cancer Institute at Oregon Health and Science University
		Clinical Trials Office - Knight Cancer Institute at Oregon Health and Science University	Ph:  503-494-1080
			Email: trials@ohsu.edu

Registry Information
Official Title		A Phase I/II Study of Patient with Newly Diagnosed Primary Central Nervous System Lymphoma Treated with Methotrexate/BBBD, and Adding Rituximab (an anti CD-20 Antibody) and Carboplatin, to the Treatment Regimen
Trial Start Date		2005-12-07
Trial Completion Date		2010-01-01 (estimated)
Registered in ClinicalTrials.gov		NCT00293475
Date Submitted to PDQ		2005-11-11
Information Last Verified		2008-12-07
NCI Grant/Contract Number		CA69533