Overview

This trial is active, not recruiting.

Conditions cardiac transplantation, skin cancer
Treatment everolimus
Phase phase 3
Targets mTOR, FKBP-12
Sponsor Hospices Civils de Lyon
Start date October 2008
End date September 2014
Trial size 175 participants
Trial identifier NCT00799188, 2007.489/32

Summary

Heart transplant is a recognized therapeutic strategy in refractory heart failure. Its success is however hampered by severe cancer occurrence and recurrence. The new m-tor inhibiting drugs Sirolimus and Everolimus have shown potential for reducing the incidence of cancer in animal models. They are potent immunosuppressant, antiproliferative and antiangiogenic drugs. This open labelled randomized multicenter study aims at evaluating the beneficial antineoplastic effect of Everolimus in 159 heart transplant patients suffering of recurrent skin cancer. Primary objective is to demonstrate a reduction in the number of new skin cancers. Secondary end point will be time of recurrence, incidence of non skin cancer, graft function following switch (including death), renal function evolution following calcineurin inhibitors reduction or withdrawal, Everolimus tolerance profile, schemes of calcineurin inhibitors reduction management in centers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
reduction of immunosuppression
(Experimental)
switch to Everolimus : 50% reduction of calcineurin inhibitors (ciclosporine or tacrolimus)
everolimus Certican
50% reduction of calcineurin inhibitors daily dose followed by further decrease or withdrawal. Everolimus will be introduced and tapered to a trough level of 6 to 10 microg/l.

Primary Outcomes

Measure
Number of skin tumors per patients requiring surgery with histology control within 2 years
time frame: 2 years

Secondary Outcomes

Measure
New skin cancer
time frame: 2 years
Number of patients with new skin cancers
time frame: 2 years
Time of recurrence
time frame: 2 years
Number and histology of other types of skin cancer
time frame: 2 years
Graft function (including acute rejection, graft loss, death)
time frame: 2 years
Renal function evolution as assessed using Cockcroft creatinine clearance and proteinuria
time frame: 2 years
Adverse events and serious adverse events
time frame: 2 years
Non skin cancer (Number and diagnostic)
time frame: 2 years
Schemes of calcineurin inhibitors reduction/withdrawal
time frame: 2 years
Immune response assessment through regulatory or effector function of blood and in situ T lymphocytes at baseline and following immunosuppression switch
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - First orthotopic heart transplant after 1st year - No rejection within previous 6 Months - Occurrence of squamous cell carcinoma, basal cell carcinoma, in situ carcinoma, Bowen disease, premalignant keratosis - Recurrence of skin cancers leading to immunosuppressive regimen modifications - Removal of a skin lesion in the past three years - Above 18 yrs and under contraceptive drugs if applicable - Informed consent given - Health coverage ongoing Exclusion Criteria: - Other non simultaneously transplanted organ - recent biopsy proven acute rejection - Proteinuria > 1g/l - Ongoing infectious disease - HIV positivity, Chronic active Hepatitis B or C. - Abnormal blood tests: transaminases >= 3UNL, Bilirubin > 34 mmol.l, albumin<35 g/l, spontaneous INR >1,3 - Hemoglobin >= 8 g/dl, White Blood Count<= 2 giga/l, platelet count <= 50 giga/l - Hypercholesterolemia>= 9 mmol/l, hypertriglyceridemia >= 8,5 mmol/l despite treatment - History of macrolid or mTor inhibitor intolerance - Previous cancer other than skin in the year prior to enrollment - Medical or surgical condition unsuitable for the trial - Breast feeding - Positive pregnancy test - Severe psychiatric disorder - Communication or language disability

Additional Information

Official title CERTICOEUR a Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. An Open Labelled Randomized Everolimus vs Calcineurin Inhibitors Multicenter Trial
Principal investigator LAURENT SEBBAG, MD
Description - Open labelled randomized Everolimus vs reduction of calcineurin inhibitors trial. 2:1 randomization design - October 10, 2008 - 159 patients (106 everolimus vs 53 calcineurin inhibitors reduction) - 175 patients (117 vs 58) - X Not yet recruiting 0 recruiting 0 no longer recruiting - Number of skin tumors per patients requiring surgery with histology control within 2 years Within 2 years of Follow up: - New skin cancer - Number of patients with new skin cancers - Time of recurrence - Number and histology of other types of skin cancer - Graft function (including acute rejection, graft loss, death) - Renal function evolution as assessed using Cockcroft creatinine clearance and proteinuria - Adverse events and serious adverse events - Non skin cancer (Number and diagnostic) - Schemes of calcineurin inhibitors reduction/withdrawal - Immune response assessment through regulatory or effector function of blood and in situ T lymphocytes at baseline and following immunosuppression switch
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.