A Pilot Study of the Use of Rituximab in the Treatment of Chronic Focal Encephalitis

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, tolerability and effectiveness of rituximab in the treatment of chronic focal encephalitis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Pacific Medical Center Research Institute
• Collaborator: Genentech, Inc.
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Diagnosis of chronic focal encephalitis

• IgG & IgM levels within normal limits

• Adequate renal function

• Stable anticonvulsant drug regimen

Exclusion Criteria:

• Evidence of significant ongoing medical condition or progressive neurologic condition (other than CFE)

• Previous treatment with rituximab

• History of significant recurrent infections, or ongoing active infection

• Receipt of a live vaccine within 4 weeks prior to treatment

• History of severe allergic reactions to humanized or murine monoclonal antibodies

• History of drug, alcohol or chemical abuse within 6 months

• Concomitant malignancies or previous malignancy

• Use of steroids or immunoglobulins during the 4 weeks prior to treatment

• Hemoglobin <8.5 gm/dL, Platelets < 100,00/mm, AST or ALT >2.5 ULN

• Positive Hepatitis B or C serology

• History of positive HIV