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Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma

Primary Purpose

Squamous Cell Skin Carcinoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sirolimus
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Skin Carcinoma focused on measuring Squamous, Renal, Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shands at the University of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sirolimus treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Measure of Squamous Cell Skin Carcinoma in Patients
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

Evaluation of Skin Tumor for Squamous Cell Skin Carcinoma
Tumor will be analyzed at baseline and time of surgical removal by both laboratory and microscopic testing.

Full Information

First Posted
December 18, 2012
Last Updated
November 9, 2018
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01764607
Brief Title
Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Skin Carcinoma
Keywords
Squamous, Renal, Transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sirolimus treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
Rapamune
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure of Squamous Cell Skin Carcinoma in Patients
Description
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.
Time Frame
Baseline, time of surgical removal (5 weeks) and 1 year.
Secondary Outcome Measure Information:
Title
Evaluation of Skin Tumor for Squamous Cell Skin Carcinoma
Description
Tumor will be analyzed at baseline and time of surgical removal by both laboratory and microscopic testing.
Time Frame
At baseline and time of surgical removal (5 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priya Gopalan, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shands at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

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Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma

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