Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma
Solid organ transplant recipients (SOTR) have a 3-5x increased occurrence of cancer in contrast to the general population with basal and squamous cell skin cancer. The use of immunosuppressant or anti-rejection drugs that are needed after SOTR is known to increase the risk of developing certain kinds of cancer. The purpose of this study is to find out how well Sirolimus (also known as Rapamune) works at treating squamous cell carcinoma in renal transplant patients.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Measure of squamous cell skin carcinoma in patients on sirolimus [ Time Frame: Baseline, time of surgical removal (5 weeks) and 1 year. ] [ Designated as safety issue: No ]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 after sirolimus therapy. [ Time Frame: At baseline and time of surgical removal (5 weeks). ] [ Designated as safety issue: No ]Tumor will be analyzed at baseline and time of surgical removal by both laboratory and microscopic testing.
- Tumor recurrence. [ Time Frame: From surgical removal to 1 year. ] [ Designated as safety issue: No ]Full skin exam done by dermatology.
- Other cancer development. [ Time Frame: Baseline,5 weeks and 1 year. ] [ Designated as safety issue: No ]Full skin exam done by dermatology.
- Tumor evaluation by western blot analysis. [ Time Frame: At baseline and time of surgical removal(Week 5). ] [ Designated as safety issue: No ]Baseline results will be recorded and and then results at time of surgical removal will be reported as increased or decreased expression in comparison to the baseline results.
- Acute and/or chronic transplant rejection. [ Time Frame: At baseline and 1 year. ] [ Designated as safety issue: Yes ]Evaluating for safety reasons of sirolimus.
- Pre-treatment biopsy immunohistochemistry and PCR testing for oncogenic viruses. [ Time Frame: Baseline. ] [ Designated as safety issue: No ]p16 will be assessed for HPV integration and analysis for presence of other oncogenic viruses, EBV, HTLV-1, HHV-8, and the Merkel Cell Virus will be done.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
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
This is a Phase II randomized study to evaluate the effectiveness of Sirolimus in treating and preventing squamous cell skin cancer carcinoma using a Simon's 2-stage design. As part of the study, after the biopsy results of the skin cancer show squamous cell carcinoma and consent had been obtain, the participant will begin taking Sirolimus. The calcineurin inhibitor (tacrolimus or cyclosporine) will be discontinued once the transplant doctors find that the participants Sirolimus is therapeutic by checking blood tests once a week x 3 weeks. Approximately 5 weeks after starting Sirolimus, the squamous cell skin cancer will be removed by a surgeon. Participant next follow up visit for the study is scheduled one year post-operatively. .The study will look at your squamous cell skin cancer under the microscope to see if sirolimus had any effect at treating your squamous cell skin cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764607
|Contact: Marlene S Sarmiento, RNfirstname.lastname@example.org|
|Contact: Priya Gopalan, MDemail@example.com|
|United States, Florida|
|Shands at the University of Florida||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: Marlene S Sarmiento, RN 352-273-8517 firstname.lastname@example.org|
|Contact: Priya Gopalan, MD 352-265-0725 email@example.com|
|Principal Investigator: Priya Gopalan, MD|
|Principal Investigator:||Priya Gopalan, MD||University of Florida|