Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
Overview
- Phase
- Phase 4
- Intervention
- Sirolimus
- Conditions
- Renal Transplant Patients at High-risk for Skin Cancer
- Sponsor
- University Hospital of Berlin
- Enrollment
- 40
- Primary Endpoint
- Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves and relates on the other hand on the dosage. Based on the encouraging results of previous, retrospective studies on patients treated with Sirolimus (SRL), these patients should be switched to an immunosuppressive regime including SRL, decreasing the dosage of calcineurin-inhibitors or converting from former immunosuppression. A conversion to a SRL-based therapy is effective in immunosuppression and safe regarding graft and patient survival.
This study was designed to assess whether a switch to a SRL-immunosuppressive therapy decreases the incidence/reoccurrence of skin neoplasm.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Recipients of renal allograft with current actinic keratosis I or II or successfully treated actinic keratosis III (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (SCC), basal cell carcinoma
- •age 18 years and older
- •minimum period of 6 month after renal transplantation
- •stable renal function and a calculated creatinine clearance of at least 40 ml/min
- •written informed consent
- •proteinuria ≤ 800 mg/d at time of enrolment
- •successfully treated solid tumor (no recurrence or metastasis in the last 2 years)
Exclusion Criteria
- •Current Sirolimus- or Everolimus- intake
- •Instable graft function (creatinine clearance \< 40 ml/min)
- •Graft rejection within the 3 previous months
- •Proteinuria \> 800 mg/d
- •Non-controlled hyperlipidemia (Cholesterol \>7,8 mmol/l (300 mg/dl), Triglycerides \> 4 mmol/l (350 mg/dl)
- •Leucopenia \< 2500/nl
- •Thrombocytopenia \< 90/nl
- •Pregnancy or breastfeeding
- •Women of childbearing age without highly effective contraception
- •Known allergy to macrolides
Arms & Interventions
Sirolimus
Patients who meet all inclusion criteria will be included into the study and randomised. If converted to Sirolimus (SRL), patients will take SRL according to the investigator's instructions and medication label, once daily preferably 4 hours after calcineurin-inhibitor medication or in case without calcineurin-inhibitor co-medication in the morning. The dose of SRL will be correlated to the former immunosuppressive therapy according to the study's conversion protocol.
Intervention: Sirolimus
Outcomes
Primary Outcomes
Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors
Time Frame: at month 24
Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors (namely SCC, basal cell carcinoma, keratoacanthoma, Bowen's disease, precancerous keratoses, actinic keratoses III)