Renal Transplant Patients at High-risk for Skin Cancer Clinical Trial
— PROSKINOfficial title:
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
| Verified date | February 2013 |
| Source | University Hospital of Berlin |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 40 |
| Est. completion date | June 2013 |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 - 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 - Acute infections (mycotic, viral or bacterial) - Current intake of other substances with known nephrotoxicity - Severe liver dysfunction - Current intake of CY3A4-inhibitors (e.g. ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or CY3A4-inductors (rifampicin, rifabutin) - sucrose-isomaltase deficiency, fructose intolerance, glucose-galactose intolerance - azathioprine: known allergy to azathioprine or 6-mercaptopurine, severe bone marrow dysfunction, pancreatitis, vaccination with live vaccine - tacrolimus: known allergy to tacrolimus - mycophenolatmofetil: known allergy to mycophenolatmofetil, neutropenia, severe active gastrointestinal tract disease, Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome, current intake of azathioprine - cyclosporine: known allergy to cyclosporine, increased intracranial pressure |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital of Berlin |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors | 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) | at month 3 | |
| Primary | Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors | 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) | at month 6 | |
| Primary | Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors | 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) | at month 9 | |
| Primary | Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors | 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) | at month 12 | |
| Primary | Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors | 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) | at month 15 | |
| Primary | Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors | 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) | at month 18 | |
| Primary | Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors | 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) | at month 21 | |
| Primary | Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors | 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) | at month 24 |