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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00799188
First received: November 26, 2008
Last updated: December 11, 2013
Last verified: December 2013
  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 inhibitors reduction management in centers.


Condition Intervention Phase
Cardiac Transplantation
Skin Cancer
Drug: Everolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CERTICOEUR a Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. An Open Labelled Randomized Everolimus vs Calcineurin Inhibitors Multicenter Trial

Resource links provided by NLM:


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 Cockcroft 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 immunosuppression switch [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: October 2008
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
reduction of immunosuppression
Experimental: 2
switch to Everolimus : 50% reduction of calcineurin inhibitors (ciclosporine or tacrolimus)
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.
Other Name: Certican

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 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
  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
HOSPICES CIVILS de LYON
Lyon, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: LAURENT SEBBAG, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00799188     History of Changes
Other Study ID Numbers: 2007.489/32
Study First Received: November 26, 2008
Last Updated: December 11, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Cardiac Transplantation
Skin cancer
Everolimus

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 26, 2014