High Dose Cyclophosphamide for Treatment of Scleroderma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fredrick M. Wigley, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00501995
First received: July 13, 2007
Last updated: June 2, 2014
Last verified: June 2014
Results First Received: March 25, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Scleroderma
Intervention: Drug: IV Cyclophosphamide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IV Cyclophosphamide (50 mg/kg)

This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .

IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)


Participant Flow:   Overall Study
    IV Cyclophosphamide (50 mg/kg)  
STARTED     6  
COMPLETED     5  
NOT COMPLETED     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients with scleroderma were considered eligible for this open-label trial if they had a diagnosis of diffuse cutaneous scleroderma and evidence of clinically active disease.

Reporting Groups
  Description
IV Cyclophosphamide (50 mg/kg) This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)

Baseline Measures
    IV Cyclophosphamide (50 mg/kg)  
Number of Participants  
[units: participants]
  6  
Age  
[units: years]
Mean ( Full Range )
  39  
  ( 19 to 60 )  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     0  
Gender  
[units: participants]
 
Female     2  
Male     4  
Region of Enrollment [1]
[units: participants]
 
United States     6  
Number of Participants with diagnosis of scleroderma  
[units: participants]
  6  
[1] Number of participants



  Outcome Measures

1.  Primary:   The Primary Endpoint Will be an Improvement in the Modified Rodnan Skin Score.   [ Time Frame: 0 to 24 months ]

2.  Secondary:   Secondary Endpoint Was Changes in the Total Severity Score (Composite) and Measures of Severity in Each Specific Organ (Organ Specific Measures).   [ Time Frame: 0-24 months ]
Results not yet reported.   Anticipated Reporting Date:   04/2014   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gwen Leatherman,R.N.,M.S.
Organization: Johns Hopkins University
phone: 410-550-8582
e-mail: gleathe@jhmi.edu


No publications provided


Responsible Party: Fredrick M. Wigley, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00501995     History of Changes
Other Study ID Numbers: 00-11-17-02
Study First Received: July 13, 2007
Results First Received: March 25, 2014
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board