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

Primary Purpose

Pemphigus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cyclophosphamide
filgrastim
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pemphigus focused on measuring immunologic disorders and infectious disorders, pemphigus, rare disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
October 1, 2008
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00010413
Brief Title
Phase II Study of High-Dose Cyclophosphamide in Patients With Refractory Pemphigus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Johns Hopkins University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pemphigus
Keywords
immunologic disorders and infectious disorders, pemphigus, rare disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
35 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
filgrastim

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant J. Anhalt
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

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

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