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A Phase II Study of Sirolimus in Renal Transplant Patients Diagnosed With New or Recurrent Squamous Cell Skin Carcinoma Currently on Calcineurin-based Immunosuppression.

Phase 2
18 Years
Open (Enrolling)
Squamous Cell Skin Carcinoma

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Trial Information

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.

Inclusion Criteria:

- Histologically or cytologically proven squamous cell skin carcinoma

- Recipient of a renal organ transplant at least one year prior to study enrollment

- Receiving a CNI for at least 6 months prior to diagnosis of skin cancer

- No current evidence of graft rejection, except low-grade, chronic graft rejection

- Measurable disease by caliper measurement

- Life expectancy > 6 months

- Age of at least 18 years

- Adequate organ and marrow function as determined by ANC, HGB, PLT, Total Bili, AST,
and creatinine clearance

- Ability to understand/willingness to sign a written informed consent form

Exclusion Criteria:

- Inability to give informed consent

- Major surgery within 4 week prior to starting study drug

- Chronic or non-healing open wounds

- Pregnant and nursing women

- Women and men of child-bearing potential must agree to use adequate contraception
prior to study entry and for the study duration

- Prior use of an mTOR inhibitor

- Pre-existing clinically significant cardiac, hepatic, pulmonary, or renal dysfunction

- HIV-positive patients

- Proteinuria (> 1 gram)

- Prior or current history of uncontrolled hyperlipidemia (cholesterol > 7.8 mmol/l or
triglycerides > 4 mmol/l)

- Currently receiving any investigational agents

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to sirolimus (mTOR inhibitors)

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Measure of squamous cell skin carcinoma in patients on sirolimus verses those on calcineurin-based immunosuppressants.

Outcome Description:

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.

Outcome Time Frame:

At baseline, time of surgical removal, and every 3 months for a total of one year.

Safety Issue:


Principal Investigator

Priya Gopalan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida


United States: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

December 2014

Related Keywords:

  • Squamous Cell Skin Carcinoma
  • Squamous
  • Renal
  • Transplant
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Basosquamous
  • Carcinoma, Squamous Cell



Shands at the University of FloridaGainesville, Florida  32610