Clinical trial NCT00133887: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Cancer
Kidney Transplantation
Keywords: Squamous cell carcinoma
kidney transplant recipients
rapamycin
Skin cancers in kidney transplant recipients
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-08-24
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess the incidence of new squamous cell carcinoma in kidney transplant recipients
timeFrame: during 5 years
Secondary outcomes:
measure: To assess the incidence of other non skin cancer in kidney transplant recipients
timeFrame: during 5 years
measure: To assess the graft survival
timeFrame: during 5 years
measure: To assess the tolerance of rapamycin
timeFrame: during 5 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot - Service de Dermatologie
Study officials:
affiliation: Hospices Civils de Lyon
name: Sylvie EUVRARD, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.