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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00335140 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
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Lymphoma |
Drug: cytarabine Drug: dexamethasone Drug: leucovorin calcium Drug: methotrexate Drug: procarbazine hydrochloride Drug: rituximab Drug: vincristine sulfate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma |
Estimated Enrollment: | 43 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive rituximab IV 3 times weekly in weeks 1-4; high-dose methotrexate IV over 2 hours in weeks 1, 3, 5, and 9; oral or IV leucovorin calcium every 6 hours for 12 doses beginning 24 hours after the start of methotrexate in weeks 1, 3, 5, and 9; vincristine IV in weeks 1, 3, 5, 7, and 9; oral procarbazine hydrochloride daily on days 1-7 in weeks 1, 5, and 9; oral dexamethasone daily in weeks 1-6; and cytarabine IV over 2 hours twice weekly in weeks 11 and 14.
Patients with positive cerebrospinal fluid also receive methotrexate intrathecally and oral leucovorin calcium every 12 hours for 8 doses beginning 24 hours after the start of methotrexate in weeks 2, 4, 6, 8, and 10.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 43 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:
Patients with inconclusive biopsy or patients who are not candidates for biopsy must have typical CT scan or MRI of the brain AND meet ≥ 1 of the following criteria:
Bideminsionally measurable disease, defined as contrast-enhancing tumor ≥ 1 cm by pretreatment MRI/CT scan
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Lode J. Swinnen, MD | Sidney Kimmel Comprehensive Cancer Center |
Investigator: | Deborah T. Blumenthal, MD | University of Utah |
Study ID Numbers: | CDR0000475776, ECOG-E1F05 |
Study First Received: | June 7, 2006 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00335140 |
Health Authority: | Unspecified |
primary central nervous system lymphoma |
Dexamethasone Immunoproliferative Disorders Rituximab Leucovorin Vincristine Central nervous system lymphoma, primary Folic Acid Calcium, Dietary |
Lymphatic Diseases Methotrexate Procarbazine Lymphoproliferative Disorders Lymphoma Cytarabine Dexamethasone acetate |
Antimetabolites Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Reproductive Control Agents Hormones Vitamins Therapeutic Uses Abortifacient Agents |
Micronutrients Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Vitamin B Complex Immune System Diseases Antineoplastic Agents, Hormonal Growth Substances Mitosis Modulators Gastrointestinal Agents Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents |