Phase II Study of High-Dose Cyclophosphamide in Patients With Refractory Pemphigus
NCT ID: NCT00010413
Last Updated: 2008-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
1999-04-30
Brief Summary
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I. Determine the response rate and 1-year event-free survival of patients with refractory pemphigus treated with high-dose cyclophosphamide.
Detailed Description
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Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for a year, and then annually thereafter.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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cyclophosphamide
filgrastim
Eligibility Criteria
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Inclusion Criteria
--Disease Characteristics--
Definitive diagnosis of pemphigus, including all of the following: Typical clinical lesions Histologically proven by skin or mucous membrane biopsy Pemphigus IgG autoantibodies in skin or mucous membrane by direct immunofluorescence (IF) Circulating pemphigus IgG autoantibodies in serum by indirect IF
Dependence on high-dose corticosteroids
Persistent disease activity despite treatment with mycophenolate mofetil or azathioprine, or inability to tolerate these drugs (for paraneoplastic pemphigus, persistent disease activity despite treatment with cyclosporine)
--Prior/Concurrent Therapy--
No concurrent cytotoxic therapy
--Patient Characteristics--
Performance status: Karnofsky 20-100%
Renal: Creatinine no greater than 2.5 mg/dL
Cardiovascular: LVEF at least 40%
Pulmonary: FVC, FEV1, or DLCO at least 50% predicted
Other: Not pregnant Fertile patients must use effective contraception during and for 9 months after study Not preterminal or moribund
18 Years
70 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Principal Investigators
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Grant J. Anhalt
Role: STUDY_CHAIR
Johns Hopkins University
Locations
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Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Countries
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Other Identifiers
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JHOC-J9912
Identifier Type: -
Identifier Source: secondary_id
JHOC-99022610
Identifier Type: -
Identifier Source: secondary_id
199/15674
Identifier Type: -
Identifier Source: org_study_id