A Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma - Article
Clinical Trial: A Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma
This study is not yet open for patient recruitment.
Verified by University of California, San Francisco January 2005
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.
|Central nervous system lymphoma |
| Drug: Intraventricular Rituximab Plus MTX ||Phase I |
MedlinePlus related topics: Eye Cancer; Lymphoma
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Expected Total Enrollment: 20
Rituximab is the first monoclonal antibody to receive FDA approval in the treatment of cancer. Intravenous administration of rituximab has been demonstrated to lead to prolongation of survival when used in combination with chemotherapy 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 and we have also previously demonstrated that direct intraventricular administration of Rituximab is able to achieve high concentrations within the cerebrospinal fluid ventricles and lumbar sac.
We will test the hypothesis that the direct intraventricular injection of Rituximab in combination with Methotrexate is safe and when used in combination in patients with recurrent brain and intraocular lymphoma. We will evaluate the safety of this combination by testing different dose levels of Rituximab. We will also measure the concentration of Rituximab in the intraocular compartments and cerebrospinal fluid at different time points after intraventricular administration to determine the pharmacokinetics of intrathecal Rituximab as well as the potential impact of Methotrexate on Rituximab distribution.
We will also test the hypothesis that the intraventricular administration of the combination of rituximab plus methotrexate has activity and is effective in the treatment of recurrent brain and intraocular lymphoma.
- Relapsed, refractory CNS lymphoma, ocular lymphoma, lymphomatous meningitis
- Tumors must be CD20 + on pathologic analysis.
- Patients must have an Ommaya reservoir (ventricular access device.
- Patients may have had prior intrathecal methotrexate, ara-C or thiotepa but must have recovered from any reversible toxicity caused by prior treatment.
- Concurrent systemic chemotherapy is allowed for treatment of disease outside the meninges with the exception of high-dose methotrexate (>500 mg/m2/d, high-dose ara-C (> 2 gm/m2/d), high-dose thiotepa (>300 mg/m2/d) or investigational agents.
- Patients must have sufficient baseline hematologic function: >1,500 granulocytes and >50,000 platelets/ul.
- Patients must have had a nuclear medicine CSF flow study performed within 30 days of treatment which shows no significant obstruction within the ventricles.
Location and Contact Information
University of California, San Francisco, San Francisco, California, 94143, United States
Stanford University Medical Center, Stanford, California, 94123, United States
Ronald Levy, MD
University of Southern California, Los Angeles, California, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, 94123, United States
MD Anderson Cancer Center, Houston, Texas, United States
James L. Rubenstein, MD PhD, Study Chair, University of California, San Francisco
Last Updated: September 21, 2005
Record first received: September 14, 2005
ClinicalTrials.gov Identifier: NCT00221325
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27
- Central Nervous System Lymphoma, Primary (National Cancer Institute)