Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yaupon Therapeutics
ClinicalTrials.gov Identifier:
NCT00168064
First received: September 7, 2005
Last updated: October 2, 2012
Last verified: October 2012
Results First Received: July 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Mycosis Fungoides
Intervention: Drug: mechlorethamine-MCH (nitrogen mustard)

  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
PG -Mechlorethamine (Nitrogen Mustard) 0.02% PG Gel Study formulation of Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
AP- Mechlorethamine 0.02% Compounded in Aquaphor Compounded Mechlorethamine-MCH (Nitrogen Mustard) in Aquaphor 0.02%

Participant Flow:   Overall Study
    PG -Mechlorethamine (Nitrogen Mustard) 0.02% PG Gel     AP- Mechlorethamine 0.02% Compounded in Aquaphor  
STARTED     130 [1]   130 [2]
COMPLETED     81     86  
NOT COMPLETED     49     44  
Adverse Event                 26                 22  
Withdrawal by Subject                 3                 4  
Lack of Efficacy                 4                 4  
Lost to Follow-up                 4                 3  
Non-compliance                 2                 3  
Concurrent Illness                 4                 3  
Subject's Best interest                 2                 2  
Various                 4                 3  
[1] 128 participants received PG formulation
[2] 127 participants received AP formulation



  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.
No text entered.

Reporting Groups
  Description
PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor Compounded mechlorethamine-MCH (Nitrogen Mustard)in Aquaphor 0.02%
Total Total of all reporting groups

Baseline Measures
    PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel     AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor     Total  
Number of Participants  
[units: participants]
  130     130     260  
Age  
[units: participants]
     
<=18 years     0     1     1  
Between 18 and 65 years     93     86     179  
>=65 years     37     43     80  
Age  
[units: years]
Mean ± Standard Deviation
  54.7  ± 14.20     56.7  ± 14.34     55.7  ± 14.28  
Gender  
[units: participants]
     
Female     53     53     106  
Male     77     77     154  
Region of Enrollment  
[units: participants]
     
United States     130     130     260  



  Outcome Measures
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1.  Primary:   Ratio of Response Rates Based on CAILS   [ Time Frame: Assessment made at Day 1 and every subsequent visit during treatment ]

2.  Secondary:   Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT)   [ Time Frame: Baseline to end of therapy ]

3.  Secondary:   Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks   [ Time Frame: Assessment made at Day 1 and every subsequent visit during treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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: H. Jeffrey Wilkins, MD
Organization: Yaupon Therapeutics
phone: 4843247935 ext 935
e-mail: hjwilkins@yaupontherapeutics.com


Publications:
Publications automatically indexed to this study:

Responsible Party: Yaupon Therapeutics
ClinicalTrials.gov Identifier: NCT00168064     History of Changes
Other Study ID Numbers: 2005NMMF-201-US
Study First Received: September 7, 2005
Results First Received: July 12, 2011
Last Updated: October 2, 2012
Health Authority: United States: Food and Drug Administration