Cutaneous squamous cell carcinoma after kidney transplantation
Conditions
Interventions
Product Name: Sirolimus
Product Code: 1
Pharmaceutical Form: Coated tablet
INN or Proposed INN: sirolimus
Current Sponsor code: 1
Sponsors
Oxford Radcliffe Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Kidney transplant recipient with ³1 biopsy-confirmed cutaneous SCC. 2. Age ³18 years and at least 12 months post-transplantation. 3. Stable graft function (estimated GFR ³20 ml/min) while on a maintenance regimen with a calcineurin inhibitor, azathioprine, mycophenolate mofetil or steroids for at least 12 weeks before randomization. 4. No acute rejection episode within 12 weeks prior to randomization. 5. Women of child-bearing potential must have a negative serum pregnancy test before randomization. Women of child-bearing potential must agree to use a medically acceptable method of contraception throughout the treatment period and for 12 weeks after discontinuation of study medication. 6. Total white blood cell count >3,000/mm3, platelet count >75,000/mm3. 7. Fasting triglycerides =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Metastatic cutaneous SCC. 2. Other malignancies (except for other skin cancers), documented after transplantation. 3. Serum creatinine at screening that has increased by >30% above the last value obtained at least 12 weeks earlier. 4. Evidence of systemic infection at the time of randomization. 5. Prior or current use of Sirolimus or any of its derivatives. 6. Use of investigational agents £ 4 weeks before randomization, except for topical dermatological products as Aldara (imiquimod) or Efudix (5-fluoro-uracil). 7. Use of immunosuppressive agents at the time of randomization other than calcineurine inhibitor, azathioprine, mycophenolate mofetil or prednisone. 8. Current use of terfenadine, cisapride, astemizole, pimozide, or cimetidine; these drugs must be discontinued before randomization. 9. Positive past medical history for documented human immunodeficiency virus (HIV) infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the recurrence rate of biopsy-confirmed cutaneous SCC with sirolimus (SRL)-based immunosuppression over a 2 year period of follow-up.;Secondary Objective: Number of hyperkeratotic skin lesions, located on: - the dorsum of the hands, the forearms, the head; Primary end point(s): Recurrence rate of biopsy-confirmed cutaneous SCC within 2 years after conversion to sirolimus-based maintenance therapy. Difference between the two treatment arms for: · The time period to occurrence of the first biopsy-confirmed recurrent SCC lesion. A survival approach will be used in which the first recurrent lesion is the event under study. · The probability of having developed at least one recurrent biopsy-confirmed SCC lesion at 2 years after randomization. This is estimated from the survival curves. · The total amount of new biopsy-confirmed SCC lesions as an average over patients, per unit time. · Number of hyperkeratotic skin lesions, located on the dorsum of hands, the forearms or the head | — |
Countries
United Kingdom
Outcome results
None listed