Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma
|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.|
|ClinicalTrials.gov Identifier: NCT01764607|
Recruitment Status : Terminated (Poor accrual)
First Posted : January 9, 2013
Results First Posted : March 3, 2015
Last Update Posted : April 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Skin Carcinoma||Drug: Sirolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Sirolimus in Renal Transplant Patients Diagnosed With New or Recurrent Squamous Cell Skin Carcinoma Currently on Calcineurin-based Immunosuppression.|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Experimental: 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.
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.
Other Name: Rapamune
- Measure of Squamous Cell Skin Carcinoma in Patients [ Time Frame: Baseline, time of surgical removal (5 weeks) and 1 year. ]Baseline: Measuring of squamous cell skin carcinoma, Week 5: Measuring and surgical removal of squamous cell skin cancer with microscopic evaluation, and in 1 year.
- Evaluation of Skin Tumor for Squamous Cell Skin Carcinoma [ Time Frame: At baseline and time of surgical removal (5 weeks). ]Tumor will be analyzed at baseline and time of surgical removal by both laboratory and microscopic testing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764607
|United States, Florida|
|Shands at the University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Priya Gopalan, MD||University of Florida|