Back to results

TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients

Primary Purpose

Skin Cancer, Kidney Transplantation

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

rapamycin

ciclosporine

tacrolimus

About this trial

This is an interventional treatment trial for Skin Cancer focused on measuring Squamous cell carcinoma, kidney transplant recipients, rapamycin, Skin cancers in kidney transplant recipients

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: First post-transplant squamous cell carcinoma in a kidney transplant recipient under calcineurin inhibitors Exclusion Criteria: Other squamous cell carcinomas in the past history More than 2 transplantations Patients not under calcineurin inhibitors Unstable graft function Non controlled hyperlipidemia (cholesterol > 7.8 mmol/l or triglycerides > 3.95 mmol/l) Leucopenia < 3000/mm3 Thrombocytopenia < 100,000/mm3 Liver dysfunction Pregnancy Allergy to macrolides

Sites / Locations

Hôpital Edouard Herriot - Service de Dermatologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

patients receiving Rapamycin

patients receiving anticalcineurin treatment

Outcomes

Primary Outcome Measures

To assess the incidence of new squamous cell carcinoma in kidney transplant recipients

Secondary Outcome Measures

To assess the incidence of other non skin cancer in kidney transplant recipients

To assess the graft survival

To assess the tolerance of rapamycin

Full Information

NCT ID

NCT00133887

First Posted

August 23, 2005

Last Updated

July 1, 2014

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT00133887

Brief Title

TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients

Official Title

Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients - Multicentric Randomized, Open-label Study of Rapamycin vs Calcineurin Inhibitors

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

5. Study Description

Brief Summary

In a population of kidney transplant recipients having developed a first squamous cell carcinoma, the aim of the study is to assess the incidence of subsequent skin cancers over 2 years in patients who are switched to rapamycin as compared to patients who are maintained under calcineurin inhibitors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Cancer, Kidney Transplantation

Keywords

Squamous cell carcinoma, kidney transplant recipients, rapamycin, Skin cancers in kidney transplant recipients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

patients receiving Rapamycin

Arm Title

Arm Type

Active Comparator

Arm Description

patients receiving anticalcineurin treatment

Intervention Type

Drug

Intervention Name(s)

rapamycin

Other Intervention Name(s)

Rapamune

Intervention Description

3 to 5 mg/day

Intervention Type

Drug

Intervention Name(s)

ciclosporine

Intervention Description

Blood residual level < or = to 125 ng/ml

Intervention Type

Drug

Intervention Name(s)

tacrolimus

Intervention Description

Blood residual level < or = to 8 ng/ml

Primary Outcome Measure Information:

Title

To assess the incidence of new squamous cell carcinoma in kidney transplant recipients

Time Frame

during 5 years

Secondary Outcome Measure Information:

Title

To assess the incidence of other non skin cancer in kidney transplant recipients

Time Frame

during 5 years

Title

To assess the graft survival

Time Frame

during 5 years

Title

To assess the tolerance of rapamycin

Time Frame

during 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sylvie EUVRARD, MD

Organizational Affiliation

Hospices Civils de Lyon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Edouard Herriot - Service de Dermatologie

City

Lyon

ZIP/Postal Code

69003

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

15753371

Citation

Aractingi S, Kanitakis J, Euvrard S, Le Danff C, Peguillet I, Khosrotehrani K, Lantz O, Carosella ED. Skin carcinoma arising from donor cells in a kidney transplant recipient. Cancer Res. 2005 Mar 1;65(5):1755-60. doi: 10.1158/0008-5472.CAN-04-2783.

Results Reference

background

PubMed Identifier

15061852

Citation

Martinez JC, Otley CC, Euvrard S, Arpey CJ, Stasko T; International Transplant-Skin Cancer Collaborative. Complications of systemic retinoid therapy in organ transplant recipients with squamous cell carcinoma. Dermatol Surg. 2004 Apr;30(4 Pt 2):662-6. doi: 10.1111/j.1524-4725.2004.30153.x.

Results Reference

background

PubMed Identifier

30016177

Citation

Dantal J, Morelon E, Rostaing L, Goffin E, Brocard A, Tromme I, Broeders N, Del Marmol V, Chatelet V, Dompmartin A, Kessler M, Serra A, Hofbauer GFL, Kamar N, Pouteil-Noble C, Kanitakis J, Roux A, Decullier E, Euvrard S; TUMORAPA Study Group. Sirolimus for Secondary Prevention of Skin Cancer in Kidney Transplant Recipients: 5-Year Results. J Clin Oncol. 2018 Sep 1;36(25):2612-2620. doi: 10.1200/JCO.2017.76.6691. Epub 2018 Jul 17.

Results Reference

derived

PubMed Identifier

22830463

Citation

Euvrard S, Morelon E, Rostaing L, Goffin E, Brocard A, Tromme I, Broeders N, del Marmol V, Chatelet V, Dompmartin A, Kessler M, Serra AL, Hofbauer GF, Pouteil-Noble C, Campistol JM, Kanitakis J, Roux AS, Decullier E, Dantal J; TUMORAPA Study Group. Sirolimus and secondary skin-cancer prevention in kidney transplantation. N Engl J Med. 2012 Jul 26;367(4):329-39. doi: 10.1056/NEJMoa1204166.

Results Reference

derived

Learn more about this trial

TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients

We'll reach out to this number within 24 hrs