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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133887
• Other study ID #: 2003.333
• Status: Completed
• Phase: Phase 3
• First received: August 23, 2005
• Last updated: July 1, 2014
• Start date: April 2004
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 2014
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation
• Skin Cancer
• Skin Neoplasms

Intervention

Drug:
• rapamycin
3 to 5 mg/day
• ciclosporine
Blood residual level < or = to 125 ng/ml
• tacrolimus
Blood residual level < or = to 8 ng/ml

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot - Service de Dermatologie	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the incidence of new squamous cell carcinoma in kidney transplant recipients		during 5 years	No
Secondary	To assess the incidence of other non skin cancer in kidney transplant recipients		during 5 years	No
Secondary	To assess the graft survival		during 5 years	No
Secondary	To assess the tolerance of rapamycin		during 5 years	Yes