Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma
Condition: Squamous Cell Skin Carcinoma
MeSH terms: Carcinoma; Skin Neoplasms
Intervention: Sirolimus
Intervention description: 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.
Intervention MeSH terms: Sirolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Squamous; Renal; Transplant

Summary:

      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.
    

Eligibility criteria:

        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