Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma

NCT01764607 | Terminated Phase 2 Results DMC

• 2 other identifiers: 514-201200086505
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Skin Carcinoma

Keywords

Squamous; Renal; Transplant

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, time of surgical removal (5 weeks) and 1 year.

Secondary Outcomes (1)

• Evaluation of Skin Tumor for Squamous Cell Skin Carcinoma

  At baseline and time of surgical removal (5 weeks).

Study Arms (1)

Sirolimus treatment

EXPERIMENTAL

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

Interventions

Sirolimus DRUG

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.

Also known as: Rapamune

Sirolimus treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Shands at the University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Priya K Gopalan
• Organization: University of Florida

gopalpk@ufl.edu

352-273-8699

Study Officials

• Priya Gopalan, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: January 9, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 14, 2018
• Results First Posted: March 3, 2015

Record last verified: 2018-11

Locations

US (1)