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Phase II Study of High-Dose Cyclophosphamide in Patients With Refractory Pemphigus

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT00010413
Collaborator
(none)
35
Enrollment
1
Location

Study Details

Study Description

Brief Summary

OBJECTIVES:
  1. Determine the response rate and 1-year event-free survival of patients with refractory pemphigus treated with high-dose cyclophosphamide.
Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PROTOCOL OUTLINE: Patients receive cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) beginning on day 10 and continuing until blood counts recover.

Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for a year, and then annually thereafter.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Study Start Date :
Apr 1, 1999
Actual Primary Completion Date :
Aug 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    PROTOCOL ENTRY 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins University School of Medicine Baltimore Maryland United States 21205

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

    • Study Chair: Grant J. Anhalt, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00010413
    Other Study ID Numbers:
    • 199/15674
    • JHOC-J9912
    • JHOC-99022610
    First Posted:
    Feb 2, 2001
    Last Update Posted:
    Oct 2, 2008
    Last Verified:
    Oct 1, 2008
    Keywords provided by , ,
    immunologic disorders and infectious disorders
    pemphigus
    rare disease
    Additional relevant MeSH terms:
    Pemphigus
    Cyclophosphamide

    Study Results

    No Results Posted as of Oct 2, 2008