Recurrent cutaneous squamous cell carcinoma under Rapamune®
| ISRCTN | ISRCTN98226084 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98226084 |
| Secondary identifying numbers | NTR388 |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 28/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J W de Fijter
Scientific
Scientific
Leiden University Medical Centrw
Department of Nephrology
C3-P22, P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 2169 |
|---|---|
| jwdefijter@lumc.nl |
Study information
| Study design | Multicentre, randomised, double blind, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised, prospective, open-label, multi-centre study comparing the efficacy and safety of conversion to sirolimus in stable renal or liver transplant recipients with a cutaneous squamous cell carcinoma |
| Study acronym | RESCUE |
| Study objectives | It is hypothesised that conversion to a regimen with Rapamune® (sirolimus), an effective immunosuppressive drug with antiproliferative properties, could diminish the recurrence rate of cutaneous squamous cell carcinoma (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. |
| Ethics approval(s) | Approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Squamous cell carcinoma (SCC) |
| Intervention | Sirolimus treatment arm: conversion to sirolimus: 1. At the time of randomisation the patient stops the purine antagonist (azathioprine or mycophenolate mofetil) or the calcineurin inhibitor (cyclosporine or tacrolimus) on day zero and starts the same day with sirolimus (day zero: loading dose; day one: maintenance dose). Between days five and seven 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sirolimus (Rapamune®) |
| Primary outcome measure | 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 | 1. Number of hyperkeratotic skin lesions, located on: the dorsum of the hands, the forearms, the head. Secondary safety: 2. Incidence and severity of biopsy-confirmed acute rejection 3. Treatment failure, defined as the occurrence of acute rejection or premature withdrawal from study medication for any reason 4. Differences in renal function as estimated by the Cockcroft-Gault equation in both renal and liver transplant recipients 5. Patient and graft survival |
| Overall study start date | 01/01/2004 |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 180 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centrw
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Wyeth Pharmaceuticals B.V. (The Netherlands)
Not defined
Not defined
P.O. Box 255
Hoofddorp
2130 AG
Netherlands
| Phone | +31 (0)23 5672567 |
|---|---|
| info-nl@wyeth.com | |
"ROR" |
https://ror.org/02bzf1224 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2013 | Yes | No |
