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 III

MedlinePlus related topics:

Cancer Kidney Transplantation Skin Cancer

Drug Information available for:

Tacrolimus Sirolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

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 ]

Estimated Enrollment:	120
Study Start Date:	April 2004
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental patients receiving Rapamycin	Drug: rapamycin 3 to 5 mg/day
2: Active Comparator 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

Contacts


Contact: Sylvie EUVRARD, MD	33 472 110 ext 322	sylvie.euvrard@chu-lyon.fr

Locations


France
	Hôpital Edouard Herriot - Service de Dermatologie	Recruiting
	LYON, France, 69003
	Contact: Sylvie EUVRARD, MD 33 472 110 ext 322 sylvie.euvrard@chu-lyon.fr
	Principal Investigator: Sylvie EUVRARD, MD

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.

Responsible Party:	Hospices Civils de Lyon ( Sylvie EUVRARD )
Study ID Numbers:	2003.333
First Received:	August 23, 2005
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00133887
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Squamous cell carcinoma

kidney transplant recipients

rapamycin

Skin cancers in kidney transplant recipients

Study placed in the following topic categories:

Sirolimus

Skin Diseases

Clotrimazole

Squamous cell carcinoma

Miconazole

Tioconazole

Tacrolimus

Skin Neoplasms

Carcinoma

Epidermoid carcinoma

Neoplasm Metastasis

Carcinoma, squamous cell

Carcinoma, Squamous Cell

Additional relevant MeSH terms:

Anti-Bacterial Agents

Anti-Infective Agents

Neoplasms

Neoplasms by Site

Immunologic Factors

Antineoplastic Agents

Antifungal Agents

Therapeutic Uses

Physiological Effects of Drugs

Antibiotics, Antineoplastic

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2008

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00133887