Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma

This study has been terminated.
(Poor accrual)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01764607
First received: December 18, 2012
Last updated: March 13, 2015
Last verified: March 2015
Results First Received: February 17, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Squamous Cell Skin Carcinoma
Intervention: Drug: Sirolimus

  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
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Reporting Groups
  Description
Sirolimus Treatment

Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.

Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy.


Participant Flow:   Overall Study
    Sirolimus Treatment  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     0  



  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.
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Reporting Groups
  Description
Sirolimus Treatment

Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.

Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy.


Baseline Measures
    Sirolimus Treatment  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures
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1.  Primary:   Measure of Squamous Cell Skin Carcinoma in Patients   [ Time Frame: Baseline, time of surgical removal (5 weeks) and 1 year. ]

2.  Secondary:   Evaluation of Skin Tumor for Squamous Cell Skin Carcinoma   [ Time Frame: At baseline and time of surgical removal (5 weeks). ]


  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: Priya K Gopalan
Organization: University of Florida
phone: 352-273-8699
e-mail: gopalpk@ufl.edu



Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01764607     History of Changes
Other Study ID Numbers: 514-2012
00086505 ( Other Grant/Funding Number: University of Florida )
Study First Received: December 18, 2012
Results First Received: February 17, 2015
Last Updated: March 13, 2015
Health Authority: United States: Food and Drug Administration