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Clinical Trials/NCT00010413
NCT00010413CompletedPhase 2

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

Johns Hopkins University1 site in 1 country35 target enrollmentStarted: April 1, 1999Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
35
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

OBJECTIVES:

I. Determine the response rate and 1-year event-free survival of patients with refractory pemphigus treated with high-dose cyclophosphamide.

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

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Other

Study Sites (1)

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