drugset / Trial / NCT00221325

A Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma

NCT00221325

Phase 1 Completed 14 enrolled University of California, San Francisco
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Rituximab is the first monoclonal antibody to receive approval in the treatment of cancer and has been proven to lead to extended survival when administered intravenously in the treatment of patients with systemic non-Hodgkin's lymphoma. We have previously demonstrated that a small fraction of Rituximab administered intravenously is able to cross the blood-brain-barrier into the brain. We will test the idea that the direct injection into the cerebrospinal fluid of Rituximab, a monoclonal antibody which attacks and kills lymphoma cells, is safe and when used in combination with methotrexate in patients with recurrent brain and intraocular lymphoma. We will also test the idea that the combination of rituximab plus methotrexate has activity and is effective in the treatment of recurrent brain and intraocular lymphoma.

Timeline

Start
2007-04
Primary completion
2012-01
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule 12 mg Intravenous
Subject Rituximab Monoclonal antibody 10 mg Intravenous
Subject Rituximab Monoclonal antibody 25 mg Intravenous