A Pilot Study of the Use of Rituximab in the Treatment of Chronic Focal Encephalitis
Launched by CALIFORNIA PACIFIC MEDICAL CENTER RESEARCH INSTITUTE · Nov 29, 2005
Trial Information
Current as of May 29, 2025
Completed
Keywords
ClinConnect Summary
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 hemisphere is involved) and epileptic seizures that are typically refractory to medical treatment (Rasmussen). Attempts to control the seizures with anticonvulsants are ineffective and the only effective treatment to date is a hemispherectomy (surgical removal of half of the brain). Children with CFE who undergo cortical resections or hemispherectomies demonstrate an inflammatory histopathology consisti...
Gender
ALL
Eligibility 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
About California Pacific Medical Center Research Institute
California Pacific Medical Center Research Institute is a leading clinical research organization affiliated with the California Pacific Medical Center in San Francisco. Focused on advancing medical knowledge and improving patient outcomes, the institute conducts innovative clinical trials across various therapeutic areas, including cardiology, oncology, and neurology. With a commitment to rigorous scientific standards and ethical research practices, the institute collaborates with academic institutions, industry partners, and healthcare providers to develop and evaluate new therapies and interventions, ultimately striving to translate research findings into effective clinical applications for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Francisco, California, United States
Patients applied
Trial Officials
Kenneth D Laxer, M.D.
Principal Investigator
California Pacific Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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