Status:
COMPLETED
Effectiveness of Rituximab in Pediatric OMS Patients.
Lead Sponsor:
National Pediatric Neuroinflammation Organization, Inc.
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Opsoclonus-myoclonus Syndrome
Opsoclonus
Eligibility:
All Genders
6-19 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to reduce the symptoms of OMS by testing rituximab (Rituxan®), to remove B lymphocytes that make antibodies and trigger brain inflammation. Evidence suggests that autoimmu...
Detailed Description
Opsoclonus-myoclonus syndrome (OMS) is a rare but pervasive, paraneoplastic neurological disorder, purported to be autoantibody-mediated. We demonstrated expansion of B-cells in cerebrospinal fluid (C...
Eligibility Criteria
Inclusion
- written consent from parents
- have symptomatic OMS
- have CSF B-cell expansion (\>1% B-cells)
- adequate renal function as indicated by normal BUN \[10-25 mg/dL\] and creatinine \[0.4-1.2 mg/dL\]
- adequate liver function, as indicated by up to 2x normal AST \[0-35 U/L\] and ALT \[0-35 U/L\].
- men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment
Exclusion
- treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (which ever is longer)
- receipt of a live vaccine within 4 weeks prior to enrollment
- previous treatment with Rituximab
- prior antibody therapy (does not include IVIg) within past 6 months
- history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- history of HIV (patients considered high risk will be screened)
- history of hepatitis B and/or hepatitis C (patients considered high risk will be screened)
- history of recurrent significant infection or history of recurrent bacterial infections
- known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
- pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment)
- significant cardiac (symptomatic arrhythmias or symptomatic structural heart disease) or pulmonary disease (including obstructive pulmonary disease)
- concomitant chemotherapy
- hemoglobin: \>13.5 gm/dL or \<10.0 gm/dL
- platelets: \<100,000/mm or \>500,000/mm K/cumm
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00244361
Start Date
June 1 2005
End Date
December 1 2007
Last Update
May 10 2011
Active Locations (1)
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1
National Pediatric Myoclonus Center, Department of Neurology, SIU School of Medicine, 751 N Rutledge St
Springfield, Illinois, United States, 62794