TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Skin Cancer Kidney Transplantation	Drug: rapamycin Drug: ciclosporine Drug: tacrolimus	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Transplantation Skin Cancer

Drug Information available for: Sirolimus Tacrolimus Everolimus Temsirolimus

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

To assess the incidence of new squamous cell carcinoma in kidney transplant recipients [ Time Frame: during 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the incidence of other non skin cancer in kidney transplant recipients [ Time Frame: during 5 years ] [ Designated as safety issue: No ]
To assess the graft survival [ Time Frame: during 5 years ] [ Designated as safety issue: No ]
To assess the tolerance of rapamycin [ Time Frame: during 5 years ] [ Designated as safety issue: Yes ]

Enrollment:	77
Study Start Date:	April 2004
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 patients receiving Rapamycin	Drug: rapamycin 3 to 5 mg/day Other Name: Rapamune
Active Comparator: 2 patients receiving anticalcineurin treatment	Drug: ciclosporine Blood residual level < or = to 125 ng/ml Drug: tacrolimus Blood residual level < or = to 8 ng/ml

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133887

Locations

France
Hôpital Edouard Herriot - Service de Dermatologie
Lyon, France, 69003

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Sylvie EUVRARD, MD

Hospices Civils de Lyon

More Information

Publications:

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.

Togel F, Hu Z, Weiss K, Isaac J, Lange C, Westenfelder C, Stasko T, Brown MD, Carucci JA, Euvrard S, Johnson TM, Sengelmann RD, Stockfleth E, Tope WD, Asselbergs FW, Diercks GF, Hillege HL, van Boven AJ, Janssen WM, Voors AA, de Zeeuw D, de Jong PE, van Veldhuisen DJ, van Gilst WH. Amelioration of Acute Renal Failure by Stem Cell Therapy--Paracrine Secretion Versus Transdifferentiation into Resident Cells: Administered Mesenchymal Stem Cells Protect against Ischemic Acute Renal Failure through Differentiation-Independent Mechanisms. Am J Physiol Renal Physiol E-pub February 15, 2005. J Am Soc Nephrol. 2005 May;16(5):1153-63. No abstract available.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Sylvie EUVRARD, Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00133887 History of Changes
Other Study ID Numbers:	2003.333
Study First Received:	August 23, 2005
Last Updated:	March 8, 2010
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:

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

Additional relevant MeSH terms:

Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Sirolimus
Everolimus
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013