A randomised, prospective,open-label, multi-centre study comparing the efficacy and safety of conversion to Sirolimus in stable renal transplant recipients with a cutaneous squamous cell carcinoma. - RESCUE

Phase 1

• Conditions: Cutaneous squamous cell carcinoma after kidney transplantation

• Registration Number: EUCTR2005-004372-20-GB
• Lead Sponsor: Oxford Radcliffe Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-22
• Study Completion: 2011-12-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 90

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 <3.95 mmol/l, cholesterol <7.8 mmol/l, with or without statins.
8. Signed and dated informed consent obtained before screening and before any tests are performed that are specific to the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified