Status:
COMPLETED
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Lymphoma
Eligibility:
All Genders
Phase:
NA
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab...
Detailed Description
OBJECTIVES: Primary * Determine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy co...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed untreated primary CNS lymphoma (PCNSL) confirmed by 1 of the following methods:
- Brain biopsy or resection
- Patients diagnosed with T-cell PCNSL allowed but will not receive rituximab on study
- Cerebrospinal fluid (CSF) cytology
- Positive CSF cytology with or without measurable intracranial disease
- Vitreal biopsy
- Histologic confirmation of vitreal lymphoma with measurable intracranial tumor
- No evidence of systemic non-Hodgkin's lymphoma
- CT scan of chest, abdomen, and pelvis or bone marrow biopsy negative for extracerebral source of lymphoma
- No evidence of pleural effusions or ascites
- MRI of brain and spine (plus gadolinium) must have measurable contrast enhancing disease unless CSF cytology is positive
- PATIENT CHARACTERISTICS:
- Karnofsky performance score 50-100%
- HIV negative
- Creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- No concurrent salicylates, nonsteroidal anti-inflammatory drugs, sulfonamides, or penicillins within the past week
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00416819
Start Date
September 1 2003
End Date
February 1 2012
Last Update
August 20 2015
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