CERTICOEUR: A Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. Everolimus Versus Calcineurin Inhibitors Multicenter Trial

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Calcineurin Inhibitors; Everolimus; Sirolimus

Criteria

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