Not Signed In -
Cancers |
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Clinical Trial: TUMORAPA 1
This study is currently recruiting patients.
Verified by Hospices Civils de Lyon August 2005
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Purpose
| 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
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
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
- 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
France
Hôpital Edouard Herriot - Service de Dermatologie, Lyon, 69003, France; Recruiting
Sylvie EUVRARD, MD, Principal Investigator
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.
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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