Status:
COMPLETED
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
Phase:
PHASE2
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 complete response rate after remission induction therapy with the combination of high-dose methotrexate (HDMTX), temozolomide, and rituximab at 4 months. Seconda...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed primary CNS lymphoma confirmed by 1 of the following methods:
- Brain biopsy or resection
- Cerebrospinal fluid (CSF) cytology
- Positive CSF cytology with or without measurable intracranial disease
- No evidence of systemic non-Hodgkin's lymphoma
- CT scan or MRI of the chest, abdomen, and pelvis AND bilateral bone marrow biopsy or unilateral biopsy with a 2cm core biopsy specimen that is negative for extracerebral source of lymphoma
- Measurable contrast-enhancing disease by MRI of the brain and spine (plus gadolinium) unless CSF cytology positive
- No evidence of pleural effusions or ascites
- PATIENT CHARACTERISTICS:
- Age
- Any age
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Hepatic
- ALT and AST ≤ 2 times upper limit of normal
- Bilirubin ≤ 2 mg/dL
- Renal
- Creatinine clearance ≥ 50 mL/min
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 6 months after study participation
- HIV negative
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Not specified
- Endocrine therapy
- Concurrent steroids for the management of symptoms related to lymphoma allowed
- Radiotherapy
- No concurrent palliative radiotherapy
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00098774
Start Date
October 1 2004
End Date
September 1 2014
Last Update
July 6 2016
Active Locations (30)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
2
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
3
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
4
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470