Status:
COMPLETED
Intrathecal Rituximab in Treating Patients With Recurrent CNS Lymphoma
Lead Sponsor:
University of California, San Francisco
Conditions:
Brain and Central Nervous System Tumors
Lymphoma
Eligibility:
All Genders
17+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them o...
Detailed Description
OBJECTIVES: Primary * Determine the safety and pharmacokinetics of intrathecal rituximab in patients with recurrent CNS lymphoma arising from CD20+ B-cell non-Hodgkin's lymphoma. Secondary * Deter...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Cytologically confirmed relapsed CNS lymphoma
- Arising from primary CNS lymphoma or systemic non-Hodgkin's lymphoma
- Evidence of brain parenchymal involvement, cerebrospinal fluid (CSF) involvement, or ocular involvement after radiation treatment or intrathecal chemotherapy
- Tumors must be CD20+ on pathologic analysis
- Refractory or persistent disease allowed
- No complete obstruction of the CSF pathway within the ventricular system unless alleviated by external beam radiotherapy or systemic chemotherapy
- No obstructive hydrocephalus
- PATIENT CHARACTERISTICS:
- Karnofsky performance status \> 50%
- Must have an Ommaya reservoir
- Granulocyte count \> 1,500/mm\^3
- Platelet count \> 50,000/mm\^3
- Anticipated survival ≥ 1 month
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from toxicity of prior therapy
- Prior intrathecal methotrexate, cytarabine, or thiotepa for CNS lymphoma allowed
- Concurrent systemic chemotherapy for treatment of disease outside meninges allowed except for high-dose methotrexate, high-dose cytarabine, high-dose thiotepa, or investigational agents
- No history of whole-brain or craniospinal radiation \< 1 week before study entry
- No history of intrathecal chemotherapy \< 1 week before study entry
- No concurrent intrathecal chemotherapy
Exclusion
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00416923
Start Date
August 1 2002
End Date
April 1 2007
Last Update
February 16 2015
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