Status:
COMPLETED
A Pilot Study of the Use of Rituximab in the Treatment of Chronic Focal Encephalitis
Lead Sponsor:
California Pacific Medical Center Research Institute
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Chronic Focal Encephalitis
Rasmussen's Encephalitis
Eligibility:
All Genders
5-25 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety, tolerability and effectiveness of rituximab in the treatment of chronic focal encephalitis.
Detailed Description
Chronic Focal Encephalitis (Rasmussen's Encephalitis) is a condition characterized by a progressive hemiparesis, cognitive decline (including loss of language skills if the language dominant hemispher...
Eligibility Criteria
Inclusion
- Diagnosis of chronic focal encephalitis
- IgG \& IgM levels within normal limits
- Adequate renal function
- Stable anticonvulsant drug regimen
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00259805
Start Date
January 1 2005
End Date
December 1 2008
Last Update
March 22 2013
Active Locations (1)
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1
California Pacific Medical Center
San Francisco, California, United States, 94115