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Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma

This study has been terminated.
(Poor accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01764607
First Posted: January 9, 2013
Last Update Posted: April 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
Results First Submitted: February 17, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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.
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 )
First Submitted: December 18, 2012
First Posted: January 9, 2013
Results First Submitted: February 17, 2015
Results First Posted: March 3, 2015
Last Update Posted: April 3, 2015