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

Last updated: July 1, 2014
Sponsor: Hospices Civils de Lyon
Overall Status: Completed

Phase

3

Condition

Skin Cancer

Malignant Melanoma

Melanoma

Treatment

N/A

Clinical Study ID

NCT00133887
2003.333
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • First post-transplant squamous cell carcinoma in a kidney transplant recipient undercalcineurin inhibitors

Exclusion

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 > 3.95mmol/l)

  • Leucopenia < 3000/mm3

  • Thrombocytopenia < 100,000/mm3

  • Liver dysfunction

  • Pregnancy

  • Allergy to macrolides

Study Design

Total Participants: 77
Study Start date:
April 01, 2004
Estimated Completion Date:
May 31, 2014

Connect with a study center

  • Hôpital Edouard Herriot - Service de Dermatologie

    Lyon, 69003
    France

    Site Not Available

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