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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00304044 |
RATIONALE: Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Leucovorin may allow higher doses of methotrexate to be given. 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. Giving methotrexate, leucovorin, and rituximab together with highly active antiretroviral therapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving methotrexate, leucovorin, and rituximab together with highly active antiretroviral therapy works in treating patients with AIDS-related primary central nervous system lymphoma.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Lymphoma |
Biological: rituximab Drug: leucovorin calcium Drug: methotrexate Procedure: antiviral therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | AIDS-Related Primary Central Nervous System Lymphoma: A Phase II Pilot Study of High-Dose Intravenous Methotrexate With Rituximab, Leucovorin Rescue and Highly Active Antiretroviral Therapy |
Estimated Enrollment: | 18 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
Patients undergo neuropsychometric testing before beginning study treatment and then at 1-2, 6, 12, 18, 24, and 36 months after completion of study treatment.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed AIDS-related primary CNS lymphoma (AR-PCNSL)
If tissue diagnosis is not possible, the following are accepted as confirmation:
No evidence of lymphoma outside of the CNS
Positive HIV serology
No multidrug resistant HIV not amenable to long term suppression based on either or both of the following:
PATIENT CHARACTERISTICS:
No evidence of other opportunistic diseases or complications of HIV infection, including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
No prior therapy for CNS lymphoma
United States, Maryland | |
NCI - HIV and AIDS Malignancy Branch | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: Robert Yarchoan, MD 301-496-8959 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | Robert Yarchoan, MD | NCI - HIV and AIDS Malignancy Branch |
Responsible Party: | NCI - Center for Cancer Research ( Robert Yarchoan ) |
Study ID Numbers: | CDR0000465218, NCI-06-C-0051, NCI-P6720 |
Study First Received: | March 15, 2006 |
Last Updated: | April 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00304044 History of Changes |
Health Authority: | Unspecified |
neurotoxicity AIDS-related primary CNS lymphoma |
Antimetabolites Immunoproliferative Disorders Vitamin B Complex Immunologic Factors Neurotoxicity Syndromes Rituximab Central Nervous System Lymphoma, Primary Leucovorin Trace Elements Folic Acid Antagonists Immunosuppressive Agents |
Antiviral Agents Folic Acid Lymphatic Diseases Calcium, Dietary Vitamins Methotrexate Micronutrients Antirheumatic Agents Lymphoproliferative Disorders Lymphoma |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leucovorin Reproductive Control Agents Therapeutic Uses Vitamins Abortifacient Agents Methotrexate Micronutrients Dermatologic Agents |
Lymphoma Nucleic Acid Synthesis Inhibitors Immunoproliferative Disorders Neoplasms by Histologic Type Vitamin B Complex Immune System Diseases Rituximab Growth Substances Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Lymphatic Diseases |