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

Primary Purpose

Cardiac Transplantation, Skin Cancer

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Everolimus
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Transplantation focused on measuring Cardiac Transplantation, Skin cancer, Everolimus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HOSPICES CIVILS de LYON

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

reduction of immunosuppression

switch to Everolimus : 50% reduction of calcineurin inhibitors (ciclosporine or tacrolimus)

Outcomes

Primary Outcome Measures

Number of skin tumors per patients requiring surgery with histology control within 2 years

Secondary Outcome Measures

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

Full Information

First Posted
November 26, 2008
Last Updated
December 11, 2013
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT00799188
Brief Title
CERTICOEUR: A Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. Everolimus Versus Calcineurin Inhibitors Multicenter Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Transplantation, Skin Cancer
Keywords
Cardiac Transplantation, Skin cancer, Everolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
reduction of immunosuppression
Arm Title
2
Arm Type
Experimental
Arm Description
switch to Everolimus : 50% reduction of calcineurin inhibitors (ciclosporine or tacrolimus)
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
Certican
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of skin tumors per patients requiring surgery with histology control within 2 years
Time Frame
2 years
Secondary Outcome Measure Information:
Title
New skin cancer
Time Frame
2 years
Title
Number of patients with new skin cancers
Time Frame
2 years
Title
Time of recurrence
Time Frame
2 years
Title
Number and histology of other types of skin cancer
Time Frame
2 years
Title
Graft function (including acute rejection, graft loss, death)
Time Frame
2 years
Title
Renal function evolution as assessed using Cockcroft creatinine clearance and proteinuria
Time Frame
2 years
Title
Adverse events and serious adverse events
Time Frame
2 years
Title
Non skin cancer (Number and diagnostic)
Time Frame
2 years
Title
Schemes of calcineurin inhibitors reduction/withdrawal
Time Frame
2 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LAURENT SEBBAG, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
HOSPICES CIVILS de LYON
City
Lyon
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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