Status:
COMPLETED
A Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma
Lead Sponsor:
University of California, San Francisco
Conditions:
Central Nervous System Lymphoma
Intraocular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
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 us...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- History of whole brain or craniospinal irradiation or intrathecal chemotherapy \< 4 days before initiation of intra-CSF administration of rituximab.
- Anticipated survival of less than one month.
- HIV infection. -
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00221325
Start Date
April 1 2007
End Date
March 1 2013
Last Update
February 16 2015
Active Locations (4)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Massachusetts General Hospital
Boston, Massachusetts, United States
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 94123
4
MD Anderson Cancer Center
Houston, Texas, United States