A Phase II Study of Sirolimus in Renal Transplant Patients Diagnosed With New or Recurrent Squamous Cell Skin Carcinoma Currently on Calcineurin-based Immunosuppression.
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. Once a
pathological diagnosis of squamous cell skin carcinoma has been made and patients consent,
they will be randomized to either continue on their current immunosuppressive regimen or
switch to sirolimus. The patients will participate in the study for one year. They will be
seen once a week over the first 3 weeks of the study to evaluate immunosuppressant drug
levels. At week 5 of the study, or sooner if determined by dermatology, patients will
receive surgery to treat their squamous cell carcinomas. Patients will continue to be
evaluated by dermatology for new skin cancers every 3 months for 1 year.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Measure of squamous cell skin carcinoma in patients on sirolimus verses those on calcineurin-based immunosuppressants.
Baseline: Measuring of squamous cell skin carcinoma, Week 5: Measuring and surgical removal of squamous cell skin cancer with microscopic evaluation, and Every 3 months: Evaluation of skin.
At baseline, time of surgical removal, and every 3 months for a total of one year.
Priya Gopalan, MD
University of Florida
United States: Food and Drug Administration
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