Methotrexate, Glucarpidase, and Leucovorin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
NCT00727831 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2014-01-27
Summary
RATIONALE: Drugs used in chemotherapy, such as methotrexate and leucovorin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Glucarpidase may help return the level of methotrexate in the blood to a safe range. Giving high-dose methotrexate together with glucarpidase and leucovorin may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of methotrexate when given together with glucarpidase and leucovorin in treating patients with newly diagnosed primary central nervous system lymphoma.
Conditions
- Chemotherapeutic Agent Toxicity
- Lymphoma
- Mucositis
- Neurotoxicity
Interventions
- DRUG
-
glucarpidase
- DRUG
-
leucovorin calcium
- DRUG
-
methotrexate
- OTHER
-
laboratory biomarker analysis
- PROCEDURE
-
quality-of-life assessment
- RADIATION
-
radiation therapy
Sponsors & Collaborators
- collaborator OTHER
-
University College, London
lead OTHER
Principal Investigators
-
Roderick Johnson, MD · Leeds General Infirmary
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-07-31
- Primary Completion
- 2011-07-31
- Completion
- 2011-07-31
Countries
- United Kingdom
Study Locations
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