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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 Chemotherapy Comprising Methotrexate, Rituximab, and Temozolomide Before Radiotherapy and Temozolomide After Radiotherapy in Patients With Primary Central Nervous System Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	18 and over	NCI	RTOG-0227 NCT00068250

Trial Description

Purpose:

Drugs used in chemotherapy such as methotrexate and temozolomide use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining methotrexate, temozolomide, and rituximab with radiation therapy may kill more cancer cells.

This phase I/II trial is studying the side effects and best dose of temozolomide when given together with methotrexate and rituximab followed by radiation therapy and to see how well they work in treating patients with primary central nervous system lymphoma.

Eligibility:

Eligibility criteria include the following:

• No systemic lymphoma
• No previous chemotherapy
• No previous radiation therapy to the brain, head, or neck
• No previous organ transplantation
• 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 followed 3 days later with a 4-hour infusion of methotrexate. Methotrexate will be repeated in weeks 3, 5, 7, and 9. Patients will also receive temozolomide by mouth once a day for 5 days in weeks 4 and 8. They will then undergo radiation therapy to the brain 5 days a week in weeks 11-13.

Beginning in week 14, patients will receive temozolomide by mouth once a day for 5 days. Temozolomide may be repeated every 4 weeks for up to 10 courses.

Quality of life will be assessed periodically. Patients will be evaluated 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

Radiation Therapy Oncology Group

Jon Glass, MD, Protocol chair		Ph: 215-503-7005; 800-533-3669 Email: jon.glass@jefferson.edu

U.S.A.
Florida
	Jacksonville
	Baptist Cancer Institute - Jacksonville
		Clinical Trials Office - Baptist Cancer Institute - Jacksonville	Ph:  904-202-7051
	Integrated Community Oncology Network at Southside Cancer Center
		Douglas Johnson, MD	Ph:  904-202-2273
	Jacksonville Beach
	Integrated Community Oncology Network
		Douglas Johnson, MD	Ph:  904-202-2273
	Jascksonville
	Baptist Medical Center South
		Douglas Johnson, MD	Ph:  904-202-2273
	Orange Park
	Integrated Community Oncology Network - Orange Park
		Douglas Johnson, MD	Ph:  904-202-2273
	Palatka
	Florida Cancer Center - Palatka
		Douglas Johnson, MD	Ph:  904-202-2273
	Saint Augustine
	Flagler Cancer Center
		Douglas Johnson, MD	Ph:  904-202-2273
Illinois
	Urbana
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph:  800-446-5532
Missouri
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		David Mansur	Ph:  314-747-7222 800-600-3606
New Jersey
	Edison
	John F. Kennedy Medical Center
		Mark Macher, MD	Ph:  732-321-7167
Ohio
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
Oregon
	Gresham
	Legacy Mount Hood Medical Center
		Clinical Trials Office - Legacy Mount Hood Medical Center	Ph:  503-413-2150
	Milwaukie
	Providence Milwaukie Hospital
		Keith Lanier, MD	Ph:  503-299-6500
	Portland
	CCOP - Columbia River Oncology Program
		Keith Lanier, MD	Ph:  503-299-6500
	Legacy Emanuel Hospital and Health Center and Children's Hospital
		Clinical Trials Office - Legacy Emanuel Hospital and Health Center and Children's Hospital	Ph:  503-413-8199
	Legacy Good Samaritan Hospital & Comprehensive Cancer Center
		Clinical Trials Office - Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Ph:  503-413-1742
	Providence Cancer Center at Providence Portland Medical Center
		Clinical Trials Office - Providence Cancer Center at Providence Portland Medical Center	Ph:  503-215-6412
	Providence St. Vincent Medical Center
		Clinical Trials Office - Providence St. Vincent Medical Center	Ph:  503-215-6412
	Tualatin
	Legacy Meridian Park Hospital
		Clinical Trials Office - Legacy Meridian Park Hospital	Ph:  503-413-1742
Pennsylvania
	Philadelphia
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Ph:  215-955-6084
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina	Ph:  843-792-9321
	Spartanburg
	CCOP - Upstate Carolina
		Clinical Trials Office - CCOP - Upstate Carolina	Ph:  800-486-5941
	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
		Clinical Trials Office - Gibbs Regional Cancer Center	Ph:  800-486-5941
Utah
	Murray
	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
		R. Jeffrey Lee, MD	Ph:  801-408-1146
	Provo
	Utah Valley Regional Medical Center - Provo
		Clinical Trials Office - Utah Valley Regional Medical Center - Provo	Ph:  801-357-7965
Washington
	Vancouver
	Southwest Washington Medical Center Cancer Center
		Keith Lanier, MD	Ph:  503-299-6500
Wisconsin
	Menomonee Falls
	Community Memorial Hospital Cancer Care Center
		Christopher Schultz, MD	Ph:  414-805-4472
	Milwaukee
	Medical College of Wisconsin Cancer Center
		Clinical Trials Office - Medical College of Wisconsin Cancer Center	Ph:  414-805-4380

Registry Information
Official Title		Phase I/II Study Of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, And Temozolomide And Post -Irradiation Temozolomide For Primary Central Nervous System Lymphoma
Trial Start Date		2003-07-22
Trial Completion Date		2010-03-22 (estimated)
Registered in ClinicalTrials.gov		NCT00068250
Date Submitted to PDQ		2003-03-25
Information Last Verified		2009-04-16
NCI Grant/Contract Number		CA21661