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van CCT (UK)

van CCT (UK)

Recurrent cutaneous squamous cell carcinoma under rapamune.

- candidate number1623
- NTR NumberNTR388
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR13-sep-2005
- Secondary IDsN/A 
- Public TitleRecurrent cutaneous squamous cell carcinoma under rapamune.
- Scientific TitleA randomized, prospective, open-label, multi-center study comparing the efficacy and safety of conversion to SIROLIMUS in stable renal or liver transplant recipients with a cutaneous squamous cell carcinoma.
- hypothesisIt is hypothesized that conversion to a regimen with sirolimus, an effective immunosuppressive drug with antiproliferative properties, could diminish the recurrence rate of cutaneous SCC. The potential usefulness of sirolimus in the prevention of (recurrent) skin carcinoma is suggested not only by in vitro and pre-clinical studies, but also by preliminary results from studies in renal transplant recipients.
- Healt Condition(s) or Problem(s) studiedSquamous cell carcinoma (SCC)
- Inclusion criteria1. Organ (kidney or liver) transplant recipient with 1 biopsy-confirmed cutaneous SCC;
2. Age 18 years and at least 12 months post-transplantation;
3. Stable graft function (estimated GFR 20 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. All female patients at risk for pregnancy must have a negative serum pregnancy test before randomization. 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 >3,000/mm3, platelet count >75,000/mm3;
7. Fasting triglycerides <3.95 mmol/l, cholesterol <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.
- Exclusion criteria1. Metastatic cutaneous SCC;
2. Other malignancies (except for other skin cancers), documented after transplantation;
3. Serum creatinine (for renal allograft recipient) or bilirubine level (for liver allograft recipient) 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 SRL 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2004
- planned closingdate1-jan-2007
- Target number of participants180
- InterventionsSirolimus treatment arm:
1. Conversion to sirolimus:
At the time of randomization the patient stops the purine antagonist (azathioprine or mycophenolate mofetil) or the calcineurin inhibitor (cyclosporine or tacrolimus) on day 0 and starts the same day with sirolimus (day 0: loading dose; day 1: maintenance dose).
Between day 5-7 a sirolimus trough level is measured and the dose adjusted to maintain/reach the defined range. (see below);
2. Sirolimus will be given as a loading dose of 8 mg, followed by a maintenance dose of 4 mg. The dose of sirolimus will be adjusted to achieve and maintain a whole blood trough concentration in the range of 5-10 ng/ml.
- Primary outcomeTo determine the recurrence rate of biopsy-confirmed cutaneous SCC with sirolimus (SRL)-based immunosuppression over a 2 year period of follow-up.
- Secondary outcomeNumber of hyperkeratotic skin lesions, located on: the dorsum of the hands, the forearms, the head.

Secondary Safety:
1. Incidence and severity of biopsy-confirmed acute rejection;
2. Treatment failure, defined as the occurrence of acute rejection or premature withdrawal from study medication for any reason;
3. Differences in renal function as estimated by the Cockcroft-Gault equation in both renal and liver transplant recipients;
4. Patient and graft survival.
- TimepointsN/A
- Trial web site
- statusinclusion stopped: follow-up
- Sponsor/Initiator Wyeth Pharmaceuticals B.V.
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryThis open-label, randomized, parallel-group, comparative, outpatient study will include stable renal transplant recipients, at least 1 year post-transplantation, from transplant centers in The Netherlands and the United Kingdom. Patients will be randomized per site with stratification for the number of biopsy-confirmed cutaneous SCC and recipient age.
- Main changes (audit trail)
- RECORD13-sep-2005 - 15-nov-2009

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