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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045539 |
RATIONALE: Drugs used in chemotherapy, such as methotrexate and thiotepa, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining methotrexate with thiotepa in treating patients who have newly-diagnosed primary CNS lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: leucovorin calcium Drug: methotrexate Drug: thiotepa |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Methotrexate and Thiotepa Chemotherapy for Patients With Newly Diagnosed Primary CNS Lymphoma |
Study Start Date: | October 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive thiotepa IV over 15 minutes on day 1. Patients also receive methotrexate IV over 4 hours on days 1 (8 hours after thiotepa) and 14. Beginning 24 hours after the start of methotrexate infusion, patients receive leucovorin calcium IV or orally every 6 hours until rescue is achieved. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving disappearance of enhancement of disease on MRI receive an additional 28-day course followed by maintenance therapy comprising thiotepa and methotrexate once a month for 11 courses.
Patients undergo neuro-ophthalmologic exams annually for 2 years.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 23-39 patients will be accrued for this study within 8-20 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary CNS lymphoma
Confirmed by 1 of the following:
CSF cytology
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Alabama | |
Comprehensive Cancer Center at University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294-3410 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
Tampa, Florida, United States, 33612-9497 | |
United States, Georgia | |
Winship Cancer Institute of Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Massachusetts | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
Josephine Ford Cancer Center at Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, North Carolina | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1096 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 |
Study Chair: | Tracy Batchelor, MD, MPH | Massachusetts General Hospital |
Study ID Numbers: | CDR0000256605, NABTT-2109, JHOC-NABTT-2109 |
Study First Received: | September 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00045539 |
Health Authority: | United States: Federal Government |
primary central nervous system lymphoma |
Folic Acid Calcium, Dietary Lymphatic Diseases Immunoproliferative Disorders Methotrexate |
Leucovorin Lymphoproliferative Disorders Lymphoma Thiotepa Central nervous system lymphoma, primary |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses Vitamins Abortifacient Agents Micronutrients Alkylating Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |
Vitamin B Complex Neoplasms by Histologic Type Immune System Diseases Growth Substances Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |