|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00010413 |
|
Date of registration:
|
02/02/2001 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Phase II Study of High-Dose Cyclophosphamide in Patients With Refractory Pemphigus
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
April 1999 |
|
Target sample size:
|
35 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00010413 |
|
Study type:
|
Interventional |
|
Study design:
|
Primary Purpose: Treatment
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Grant J. Anhalt |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Johns Hopkins University |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Pemphigus
|
|
Intervention(s)
|
|
Drug: cyclophosphamide
|
|
Drug: filgrastim
|
|
Secondary ID(s)
|
|
JHOC-J9912
|
|
JHOC-99022610
|
|
199/15674
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|