Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma
This study is currently recruiting participants.
Verified May 2013 by University of Florida
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01764607
First received: December 18, 2012
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
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 compare sirolimus (an immunosuppressant drug) and calcineurin inhibitors (CNIs: also immunosuppressant drugs) and how they affect invasive squamous cell carcinomas in renal transplant patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Squamous Cell Skin Carcinoma |
Drug: Sirolimus Drug: Calcineurin inhibitor-based immunosuppressant (CNI) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by University of Florida:
Primary Outcome Measures:
- Measure of squamous cell skin carcinoma in patients on sirolimus verses those on calcineurin-based immunosuppressants. [ Time Frame: At baseline, time of surgical removal, and every 3 months for a total of one year. ] [ Designated as safety issue: No ]Baseline: Measuring of squamous cell skin carcinoma, Week 5: Measuring and surgical removal of squamous cell skin cancer with microscopic evaluation, and Every 3 months: Evaluation of skin.
Secondary Outcome Measures:
- Evaluation of skin tumor for squamous cell skin carcinoma after sirolimus therapy. [ Time Frame: At baseline and time of surgical removal. ] [ Designated as safety issue: No ]Tumor will be analyzed at baseline and time of surgical removal by both laboratory and microscopic testing.
- Tumor recurrence. [ Time Frame: Every 3 months for 1 year. ] [ Designated as safety issue: No ]Full skin exam done by dermatology.
- Response rate of squamous cell carcinomas to sirolimus therapy verses calcineurin-based immunosuppressant therapy. [ Time Frame: At baseline and time of surgical removal. ] [ Designated as safety issue: No ]Tumor will be analyzed by pathology.
- Other cancer development. [ Time Frame: From time of enrollment and every 3 months for 1 year. ] [ Designated as safety issue: No ]
- Tumor evaluation by western blot analysis. [ Time Frame: At baseline and time of surgical removal. ] [ Designated as safety issue: No ]Baseline results will be recorded and and then results at time of surgical removal will be reported as increased or decreased expression in comparison to the baseline results.
- Acute and/or chronic transplant rejection. [ Time Frame: At baseline and 1 year. ] [ Designated as safety issue: Yes ]Evaluating for safety reasons of sirolimus.
- Pre-treatment biopsy immunohistochemistry and PCR testing for oncogenic viruses. [ Time Frame: Baseline. ] [ Designated as safety issue: No ]p16 will be assessed for HPV integration and analysis for presence of other oncogenic viruses, EBV, HTLV-1, HHV-8, and the Merkel Cell Virus will be done.
| Estimated Enrollment: | 106 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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
|
|
Active Comparator: Calineurin inhibitor-based immunosuppressant (CNI)
This group will be considered the control group and will have the same time points of tumor measurement at randomization and 5 weeks later. After tumor removal, patients may be switch to sirolimus treatment. Nephrology will determine/manage the patient's immunosuppressant therapy.
|
Drug: Calcineurin inhibitor-based immunosuppressant (CNI)
Patients randomized to this arm of the study will continue to receive their CNI as prescribed by Nephrology. The Nephrology team will determine/manage the immunosuppressant medications for these patients.
Other Names:
|
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. Once a pathological diagnosis of squamous cell skin carcinoma has been made and patients consent, they will be randomized to either continue on their current immunosuppressive regimen or switch to sirolimus. The patients will participate in the study for one year. They will be seen once a week over the first 3 weeks of the study to evaluate immunosuppressant drug levels. At week 5 of the study, or sooner if determined by dermatology, patients will receive surgery to treat their squamous cell carcinomas. Patients will continue to be evaluated by dermatology for new skin cancers every 3 months for 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 > 7.8 mmol/l or triglycerides > 4 mmol/l)
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764607
Contacts
| Contact: Socorro A Pata, RN | 352-273-5516 | spata@ufl.edu |
| Contact: Priya Gopalan, MD | 352-265-0725 | priya.gopalan@medicine.ufl.edu |
Locations
| United States, Florida | |
| Shands at the University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Socorro A Pata, RN 352-273-5516 spata@ufl.edu | |
| Contact: Priya Gopalan, MD 352-265-0725 priya.gopalan@medicine.ufl.edu | |
| Principal Investigator: Priya Gopalan, MD | |
Sponsors and Collaborators
University of Florida
Investigators
| Principal Investigator: | Priya Gopalan, MD | University of Florida |
More Information
No publications provided
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT01764607 History of Changes |
| Other Study ID Numbers: | 514-2012, 00086505 |
| Study First Received: | December 18, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Florida:
|
Squamous Renal Transplant |
Additional relevant MeSH terms:
|
Carcinoma Skin Neoplasms Carcinoma, Basal Cell Carcinoma, Basosquamous Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Skin Diseases Neoplasms, Basal Cell Neoplasms, Squamous Cell |
Immunosuppressive Agents Sirolimus Everolimus Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 22, 2013