Recurrent cutaneous squamous cell carcinoma under Rapamune®
- Conditions
- Squamous cell carcinoma (SCC)CancerCarcinoma
- Registration Number
- ISRCTN98226084
- Lead Sponsor
- Wyeth Pharmaceuticals B.V. (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 180
1. Organ (kidney or liver) transplant recipient with biopsy-confirmed cutaneous SCC
2. Aged over 18 years and at least 12 months post-transplantation
3. Stable graft function (estimated glomerular filtration rate [GFR] more than 20 ml/min) while on a maintenance regimen with a calcineurin inhibitor, azathioprine, mycophenolate mofetil or steroids for at least 12 weeks before randomisation
4. No acute rejection episode within 12 weeks prior to randomisation
5. All female patients at risk for pregnancy must have a negative serum pregnancy test before randomisation. Female patients at risk for pregnancy 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 more than 3000/mm^3, platelet count more than 75,000/mm^3
7. Fasting triglycerides less than 3.95mmol/l, cholesterol less than 7.8 mmol/l, with or without statins
8. Signed, dated and witnessed (Institutional Review Board [IRB] or Independent Ethics Committee [IEC] approved) informed consent before screening and before any tests are performed that are specific to the protocol
1. Metastatic cutaneous SCC
2. Other malignancies (except for other skin cancers), documented after transplantation
3. Serum creatinine (for renal allograft recipient) or bilirubin level (for liver allograft recipient) at screening that has increased by more than 30% above the last value obtained at least 12 weeks earlier
4. Evidence of systemic infection at the time of randomisation
5. Prior or current use of SRL or any of its derivatives
6. Use of investigational agents for less than four weeks before randomisation, except for topical dermatological products as Aldara® (imiquimod) or Efudix® (5-fluoro-uracil)
7. Use of immunosuppressive agents (at the time of randomisation) other than calcineurin inhibitor, azathioprine, mycophenolate mofetil or prednisone
8. Current use of terfenadine, cisapride, astemizole, pimozide, or cimetidine; these drugs must be discontinued before randomisation
9. Positive past medical history for documented human immunodeficiency virus (HIV) infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the recurrence rate of biopsy-confirmed cutaneous SCC with sirolimus (SRL)-based immunosuppression over a two year period of follow-up.
- Secondary Outcome Measures
Name Time Method 1. Number of hyperkeratotic skin lesions, located on: the dorsum of the hands, the forearms, the head.<br><br>Secondary safety:<br>2. Incidence and severity of biopsy-confirmed acute rejection<br>3. Treatment failure, defined as the occurrence of acute rejection or premature withdrawal from study medication for any reason<br>4. Differences in renal function as estimated by the Cockcroft-Gault equation in both renal and liver transplant recipients<br>5. Patient and graft survival