Clinical trial NCT00866684: Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
Official title: Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Skin Cancer
Keywords: Renal transplant-patients with high-risk for skin cancer
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-03-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves (i.e., azathioprine) and relates on the other hand on the dosage (i.e., calcineurin-inhibitors). 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.

Detailed description: Patients who meet all inclusion criteria will be included into the study and randomised. If converted to 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.

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 and/or premalignant neoplastic skin lesions
* 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, Triglycerides \> 4)
* Leucopenia \< 2500/nl
* Thrombocytopenia \< 90/nl
* Pregnancy or breastfeeding
* Women of childbearing age without highly effective contraception (= defined as those which result in a low failure rate (i.e. less than 1 % per year))
* Known allergy to macrolides
* Current participation in other studies
* Refusal to sign informed consent form
* Neoplasm other than defined as inclusion criteria
* All contraindications to SRL (see package insert, appendix)
* Persons who are detained officially or legally to an official institute

Primary outcomes:
measure: Number of Events of Reoccurrence of Skin Cancer
timeFrame: 24 month
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Hautklinik
state: Bavaria
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Medizinische Klinik IV
state: Bavaria
city: München
country: Germany
facility: Klinikum der LMU München, Medizinische Poliklinik Innenstadt
state: Bavaria
city: München
country: Germany
facility: Klinikum der LMU München, Klinik und Poliklinik für Dermatologie
state: Bavaria
city: München
country: Germany
facility: Klinikum rechts der Isar, Klinik und Poliklinik für Dermatologie und Allergologie
state: Bavaria
city: München
country: Germany
facility: Klinikum rechts der Isar, II. Medizinische Klinik und Poliklinik
state: Bavaria
city: Regensburg
country: Germany
facility: Universität Regensburg, Dermatologie
state: Bavaria
city: Regensburg
country: Germany
facility: Universität Regensburg, Nephrologie Innere Medizin II
state: Bavaria
city: Köln
country: Germany
facility: Kliniken der Stadt Köln, Medizinische Klinik I
state: North Rhine-Westphalia
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten
state: North Rhine-Westphalia
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Med. Klinik und Poliklinik D
state: North Rhine-Westphalia
city: Wuppertal
country: Germany
facility: HELIOS Klinikum Wuppertal, Zentrum für Dermatologie, Allergologie und Umweltmedizin
state: North Rhine-Westphalia
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Klinik für Nieren- und Hochdruckkrankheiten
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charité Universitätsmedizin, Klinik für Dermatologie, Venerologie und Allergologie
Study officials:
affiliation: Charite University, Berlin, Germany
name: Petra Reinke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: