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

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