Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of California, San Francisco
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 * 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.
Age
17–any
Sex
ALL
Healthy volunteers
Not accepted
