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

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00799188

Purpose

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.

Condition	Intervention	Phase
Cardiac Transplantation Skin Cancer	Drug: Everolimus	Phase III

MedlinePlus related topics: Cancer Heart Transplantation Hospice Care Skin Cancer

Drug Information available for: Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	CERTICOEUR a Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. An Open Labelled Randomized Everolimus vs Calcineurin Inhibitors Multicenter Trial

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Number of skin tumors per patients requiring surgery with histology control within 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

New skin cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Number of patients with new skin cancers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Time of recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Number and histology of other types of skin cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Graft function (including acute rejection, graft loss, death) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Renal function evolution as assessed using cockroft creatinine clearance and proteinuria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Adverse events and serious adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Non skin cancer (Number and diagnostic) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Schemes of calcineurin inhibitors reduction/withdrawal [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Immune response assessment through regulatory or effector function of blood and in situ T lymphocytes at baseline and following immusuppression switch [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	175
Study Start Date:	October 2008
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention reduction of immunosuppression
2: Experimental switch to Everolimus : 50% reduction of calcineurin inbitors (ciclosporine or tacrolimus)	Drug: Everolimus 50% reduction of calcineurin inbitors daily dose followed by further decrease or withdrawal. Everolimus will be introduced and tapered to a trough level of 6 to 10 microg/l.

Detailed 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 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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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, 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
Breast feeding
Positive pregnancy test
Severe psychiatric disorder
Communication or language disability

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799188

Contacts

Contact: LAURENT SEBBAG, Doctor

33472357994.

laurent.sebbag@chu-lyon.fr

Locations

France
HOSPICES CIVILS de LYON	Recruiting
LYON, France
Contact: LAURENT SEBBAG, MD 33472357994. laurent.sebbag@chu-lyon.fr
Contact: LAURENT SEBBAG, MD 33472357994. laurent.sebbag@chu-lyon.fr
Principal Investigator: LAURENT SEBBAG, MD

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:	LAURENT SEBBAG, MD	Hospices Civils de Lyon
Principal Investigator:	LAURENT SEBBAG, MD	Hospices Civils de Lyon

More Information

Responsible Party:	Pôle de Transplantation Hôpital Louis Pradel ( Dr Laurent SEBBAG )
Study ID Numbers:	2007.489/32
Study First Received:	November 26, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00799188
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Cardiac Transplantation
Skin cancer
Everolimus

Study placed in the following topic categories:

Everolimus
Skin Diseases
Neoplasm Metastasis
Skin Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Immunologic Factors

Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009