Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01764607
Recruitment Status : Terminated (Poor accrual)
First Posted : January 9, 2013
Results First Posted : March 3, 2015
Last Update Posted : April 3, 2015
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Solid organ transplant recipients (SOTR) have a 3-5x increased occurrence of cancer in contrast to the general population with basal and squamous cell skin cancer. The use of immunosuppressant or anti-rejection drugs that are needed after SOTR is known to increase the risk of developing certain kinds of cancer. The purpose of this study is to find out how well Sirolimus (also known as Rapamune) works at treating squamous cell carcinoma in renal transplant patients.

Condition or disease Intervention/treatment Phase
Squamous Cell Skin Carcinoma Drug: Sirolimus Phase 2

Detailed Description:
This is a Phase II randomized study to evaluate the effectiveness of Sirolimus in treating and preventing squamous cell skin cancer carcinoma using a Simon's 2-stage design. As part of the study, after the biopsy results of the skin cancer show squamous cell carcinoma and consent had been obtain, the participant will begin taking Sirolimus. The calcineurin inhibitor (tacrolimus or cyclosporine) will be discontinued once the transplant doctors find that the participants Sirolimus is therapeutic by checking blood tests once a week x 3 weeks. Approximately 5 weeks after starting Sirolimus, the squamous cell skin cancer will be removed by a surgeon. Participant next follow up visit for the study is scheduled one year post-operatively. .The study will look at your squamous cell skin cancer under the microscope to see if sirolimus had any effect at treating your squamous cell skin cancer.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Sirolimus in Renal Transplant Patients Diagnosed With New or Recurrent Squamous Cell Skin Carcinoma Currently on Calcineurin-based Immunosuppression.
Study Start Date : April 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sirolimus treatment
Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.
Drug: Sirolimus
Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy.
Other Name: Rapamune

Primary Outcome Measures :
  1. Measure of Squamous Cell Skin Carcinoma in Patients [ Time Frame: Baseline, time of surgical removal (5 weeks) and 1 year. ]
    Baseline: Measuring of squamous cell skin carcinoma, Week 5: Measuring and surgical removal of squamous cell skin cancer with microscopic evaluation, and in 1 year.

Secondary Outcome Measures :
  1. Evaluation of Skin Tumor for Squamous Cell Skin Carcinoma [ Time Frame: At baseline and time of surgical removal (5 weeks). ]
    Tumor will be analyzed at baseline and time of surgical removal by both laboratory and microscopic testing.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically proven squamous cell skin carcinoma
  • Recipient of a renal organ transplant at least one year prior to study enrollment
  • Receiving a CNI for at least 6 months prior to diagnosis of skin cancer
  • No current evidence of graft rejection, except low-grade, chronic graft rejection
  • Measurable disease by caliper measurement
  • Life expectancy > 6 months
  • Age of at least 18 years
  • Adequate organ and marrow function as determined by ANC, HGB, PLT, Total Bili, AST, and creatinine clearance
  • Ability to understand/willingness to sign a written informed consent form

Exclusion Criteria:

  • Inability to give informed consent
  • Major surgery within 4 week prior to starting study drug
  • Chronic or non-healing open wounds
  • Pregnant and nursing women
  • Women and men of child-bearing potential must agree to use adequate contraception prior to study entry and for the study duration
  • Prior use of an mTOR inhibitor
  • Pre-existing clinically significant cardiac, hepatic, pulmonary, or renal dysfunction
  • HIV-positive patients
  • Proteinuria (> 1 gram)
  • Prior or current history of uncontrolled hyperlipidemia (cholesterol > 302 mg/dl or triglycerides 354 mg/dl
  • Currently receiving any investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sirolimus (mTOR inhibitors)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01764607

United States, Florida
Shands at the University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Principal Investigator: Priya Gopalan, MD University of Florida

Responsible Party: University of Florida Identifier: NCT01764607     History of Changes
Other Study ID Numbers: 514-2012
00086505 ( Other Grant/Funding Number: University of Florida )
First Posted: January 9, 2013    Key Record Dates
Results First Posted: March 3, 2015
Last Update Posted: April 3, 2015
Last Verified: March 2015

Keywords provided by University of Florida:

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Skin Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs