Clinical Trial: TUMORAPA 1

This study is currently recruiting patients.
Verified by Hospices Civils de Lyon August 2005

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

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 cancers in kidney transplant recipients
 Drug: rapamycine
 Drug: ciclosporine
 Drug: tacrolimus
Phase III

MedlinePlus consumer health information 

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 Anlcineurin Inhibitors

Further Study Details: 
Primary Outcomes: To assess the incidence of new squamous cell carcinoma in kidney transplant recipients.
Secondary Outcomes: To assess the incidence of other non skin cancer in kidney transplant recipients.; To assess the graft survival; To assess the tolerance of rapamycin
Expected Total Enrollment:  206

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Other squamous cell carcinomas in the past history
  • More than 2 transplantations
  • Patients not under calcineurin inhibitors
  • Instable graft function
  • Non controlled hyperelipemia (cholesterol>7.8mmol/l or triglycerids>3.95 mmol/l)
  • Leucopenia < 3000
  • Thrombocytopenia <100 000/mm3
  • Liver dysfunction
  • Pregnancy
  • Allergy to macrolides.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00133887

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

France
      Hôpital Edouard Herriot - Service de Dermatologie, Lyon,  69003,  France; Recruiting
Sylvie EUVRARD, MD  33 472 110  Ext. 322    sylvie.euvrard@chu-lyon.fr 
Sylvie EUVRARD, MD,  Principal Investigator

Study chairs or principal investigators

Sylvie EUVRARD, MD,  Principal Investigator,  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.

Study ID Numbers:  2003.333
Last Updated:  August 23, 2005
Record first received:  August 23, 2005
ClinicalTrials.gov Identifier:  NCT00133887
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-30

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