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CERTICOEUR: A Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. Everolimus Versus Calcineurin Inhibitors Multicenter Trial
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Active
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18 to 65
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Other
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2007.489/32
NCT00799188
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Trial Description
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 inbitors reduction management in centers. Further Study Information - Open labelled randomized Everolimus vs reduction of calcineurin inhibitors trial. 2:1 randomization design
- 159 patients (106 everolimus vs 53 calcineurin inhibitors reduction)
- 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: - Number of patients with new skin cancers
- Number and histology of other types of skin cancer
- Graft function (including acute rejection, graft loss, death)
- Renal function evolution as assessed using cockroft 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 immusuppression switch
Eligibility Criteria Inclusion Criteria: - First orthotopic heart transplant after 1st year
- No rejection within previous 6 Months
- Occurrence within the three previous years of squamous cell carcinoma, basal cell carcinoma, in situ carcinoma, Bowen disease, premalignant keratosis.
- Recurrence of skin cancers leading to immunosuppressive regimen modifications
- Above 18 yrs and under contraceptive drugs if applicable
Exclusion Criteria: - Other non simultaneously transplanted organ
- recent biopsy proven acute rejection
- Ongoing infectious disease
- HIV positivity, Chronic active Hepatitis B or C.
- Abnormal blood tests: transaminases >= 3UNL, Bilirubine > 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 within last 5 years
- Medical or surgical condition unsuitable for the trial
- Severe psychiatric disorder
- Communication or language disability
Trial Contact Information
Trial Lead Organizations/Sponsors Centre Hospitalier Lyon Sud | LAURENT SEBBAG, MD | | Principal Investigator |
| LAURENT SEBBAG, MD | | Principal Investigator |
Trial Sites
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00799188
Information obtained from ClinicalTrials.gov on November 28, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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