Clinical trial · Interventional
Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma
A Phase II Study of Sirolimus in Renal Transplant Patients Diagnosed With New or Recurrent Squamous Cell Skin Carcinoma Currently on Calcineurin-based Immunosuppression.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Skin Carcinoma | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sirolimus treatment
- 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.
- interventionNames
- Drug: Sirolimus
Primary outcomes (1)
- measure
- Measure of Squamous Cell Skin Carcinoma in Patients
- timeFrame
- Baseline, time of surgical removal (5 weeks) and 1 year.
- 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.
Secondary outcomes (1)
- measure
- Evaluation of Skin Tumor for Squamous Cell Skin Carcinoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available