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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00068250 |
Purpose
RATIONALE: 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.
PURPOSE: 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: methotrexate Drug: temozolomide Radiation: radiation therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| 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 |
| Estimated Enrollment: | 64 |
| Study Start Date: | July 2003 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a phase I dose-escalation study of temozolomide in combination with methotrexate and rituximab before radiotherapy, followed by a phase II study.
Phase I
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 0 of 3 or 1 of 6 patients experience dose-limiting toxicity.
Phase II
Quality of life is assessed at baseline, at weeks 10 and 13, every 2 months during post-radiotherapy temozolomide therapy, at the end of therapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 52-64 patients (up to 18 patients for phase I and 46 patients for phase II) will be accrued for this study within 19 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Cytologically confirmed primary CNS lymphoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, Florida | |
| Baptist Cancer Institute - Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Clinical Trials Office - Baptist Cancer Institute - Jacksonvil 904-202-7051 | |
| Integrated Community Oncology Network - Orange Park | Recruiting |
| Orange Park, Florida, United States, 32073 | |
| Contact: Douglas W. Johnson, MD 904-202-2273 | |
| United States, Michigan | |
| Borgess Medical Center | Recruiting |
| Kalamazoo, Michigan, United States, 49001 | |
| Contact: Raymond S. Lord, MD 269-373-7458 | |
| Bronson Methodist Hospital | Recruiting |
| Kalamazoo, Michigan, United States, 49007 | |
| Contact: Raymond S. Lord, MD 269-373-7458 | |
| West Michigan Cancer Center | Recruiting |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Contact: Clinical Trials Office - West Michigan Cancer Center 269-373-7458 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: David B. Mansur 314-747-7222 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | Recruiting |
| Las Vegas, Nevada, United States, 89106 | |
| Contact: John A. Ellerton, MD, CM 702-384-0013 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
| United States, Oregon | |
| CCOP - Columbia River Oncology Program | Recruiting |
| Portland, Oregon, United States, 97225 | |
| Contact: Keith S. Lanier, MD 503-299-6500 | |
| Providence Cancer Center at Providence Portland Medical Center | Recruiting |
| Portland, Oregon, United States, 97213-2967 | |
| Contact: Clinical Trials Office - Providence Cancer Center at Providenc 503-215-6412 | |
| Providence Milwaukie Hospital | Recruiting |
| Milwaukie, Oregon, United States, 97222 | |
| Contact: Keith S. Lanier, MD 503-299-6500 | |
| Providence St. Vincent Medical Center | Recruiting |
| Portland, Oregon, United States, 97225 | |
| Contact: Clinical Trials Office - Providence St. Vincent Medical Center 503-215-6412 | |
| United States, Pennsylvania | |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer 215-955-6084 | |
| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni 843-792-9321 | |
| United States, Utah | |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Recruiting |
| Murray, Utah, United States, 84157 | |
| Contact: R. Jeffrey Lee, MD 801-408-1146 | |
| Utah Valley Regional Medical Center - Provo | Recruiting |
| Provo, Utah, United States, 84604 | |
| Contact: Clinical Trials Office - Utah Valley Regional Medical Center - 801-357-7965 | |
| United States, Washington | |
| Southwest Washington Medical Center Cancer Center | Recruiting |
| Vancouver, Washington, United States, 98668 | |
| Contact: Keith S. Lanier, MD 503-299-6500 | |
| United States, Wisconsin | |
| Community Memorial Hospital Cancer Care Center | Recruiting |
| Menomonee Falls, Wisconsin, United States, 53051 | |
| Contact: Christopher J. Schultz, MD 414-805-4472 | |
| Medical College of Wisconsin Cancer Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380 | |
| Canada, Ontario | |
| London Regional Cancer Program at London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 4L6 | |
| Contact: David A. Macdonald 519-685-8615 | |
| Study Chair: | Jon Glass, MD | Kimmel Cancer Center (KCC) |
More Information
| Responsible Party: | Radiation Therapy Oncology Group ( Walter John Curran, Jr ) |
| Study ID Numbers: | CDR0000301563, RTOG-0227 |
| Study First Received: | September 10, 2003 |
| Last Updated: | November 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00068250 History of Changes |
| Health Authority: | Unspecified |
|
primary central nervous system lymphoma |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses Abortifacient Agents Methotrexate Alkylating Agents Lymphoma Dermatologic Agents Nucleic Acid Synthesis Inhibitors Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Rituximab Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Temozolomide Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders |