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

Skin Cancer Clinical Trial

— CERTICOEUR  

Official title:

CERTICOEUR a Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. An Open Labelled Randomized Everolimus vs Calcineurin Inhibitors Multicenter Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00799188
• Other study ID #: 2007.489/32
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 26, 2008
• Last updated: December 11, 2013
• Start date: October 2008

Study information

• Verified date: December 2013
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Transplantation
• Skin Cancer
• Skin Neoplasms

Intervention

Drug:
• Everolimus
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.

Locations

Country	Name	City	State
France	HOSPICES CIVILS de LYON	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of skin tumors per patients requiring surgery with histology control within 2 years		2 years	No
Secondary	New skin cancer		2 years	No
Secondary	Number of patients with new skin cancers		2 years	No
Secondary	Time of recurrence		2 years	No
Secondary	Number and histology of other types of skin cancer		2 years	No
Secondary	Graft function (including acute rejection, graft loss, death)		2 years	No
Secondary	Renal function evolution as assessed using Cockcroft creatinine clearance and proteinuria		2 years	No
Secondary	Adverse events and serious adverse events		2 years	Yes
Secondary	Non skin cancer (Number and diagnostic)		2 years	No
Secondary	Schemes of calcineurin inhibitors reduction/withdrawal		2 years	No
Secondary	Immune response assessment through regulatory or effector function of blood and in situ T lymphocytes at baseline and following immunosuppression switch		2 years	No