Intrathecal Rituximab in Treating Patients With Recurrent CNS Lymphoma
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 or carry cancer-killing substances to them. Giving rituximab intrathecally may be an effective treatment for recurrent CNS lymphoma.
PURPOSE: This phase I trial is studying the side effects and best dose of intrathecal rituximab in treating patients with recurrent CNS lymphoma.
Brain and Central Nervous System Tumors
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Intrathecal Rituximab in Patients With Recurrent CNS Lymphoma|
- Adverse events as a measure of safety of intrathecal administration of Rituximab [ Time Frame: up to 5 years after completion of 5 week study treatment ] [ Designated as safety issue: Yes ]
- Serum concentration of Rituximab [ Time Frame: during 5 weeks of study treatment ] [ Designated as safety issue: Yes ]
- Cerebrospinal Fluid (CSF) concentration of Rituximab [ Time Frame: during 5 weeks of study treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2002|
|Study Completion Date:||April 2007|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
Experimental: intrathecal rituximab
3 dose levels of intrathecal rituximab, 10mg, 25mg, 50mg
- Determine the safety and pharmacokinetics of intrathecal rituximab in patients with recurrent CNS lymphoma arising from CD20+ B-cell non-Hodgkin's lymphoma.
- Determine the efficacy of intrathecal rituximab.
- Determine the molecular pathogenesis of lymphomatous meningitis.
- Determine the molecular basis for response or lack of response to rituximab.
- Identify molecular markers specific for lymphomatous meningitis that will be useful for prognostic evaluation of peripheral lymphomas.
- Determine the quality of life of patients treated with intrathecal rituximab.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive rituximab intrathecally over 10 minutes on day 1 in week 1 and on days 1 and 4 in weeks 2-5 in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial response with no rituximab-related neurotoxicity may continue to receive treatment beyond 5 weeks.
Cohorts of patients receive escalating doses of rituximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which fewer than 1/3 of patients experience dose-limiting toxicity.
Quality of life is assessed at baseline and at the completion of study treatment.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416923
|Principal Investigator:||James L. Rubenstein, MD, PhD||University of California, San Francisco|