Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma

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.

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 > 302 mg/dl or
triglycerides 354 mg/dl

- 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