Preventing Squamous Cell Skin Cancer

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is proposed based on our work showing that the diabetes drug Pioglitazone strongly inhibits growth of tissue cultured squamous cell carcinoma (SCC) of the skin. This occurs at concentrations readily achievable by oral administration of this drug using doses currently approved for the treatment of diabetes. In our study, we propose to enroll 40 non-diabetic adult subjects (18-80 yrs of age inclusive) with a documented clinical history of frequent occurrence of skin squamous cell cancer to receive Pioglitazone (Actos®,Takeda Pharmaceuticals). Each subject will receive usual care for all new tumors they develop while on study (i.e, excision and plastic repair). The study protocol will randomize (1:1) patients for 6 months of observation followed by 6 months of treatment (group 1) or 6 months of treatment with drug followed by observation for 6 months (to examine washout effects). The biopsy specimens collected on and off therapy will be examined to determine if they express AKR1C3, an enzyme we believe increases resistance of SCC to prostaglandin inflammatory mediators. We will also examine the histologic grade of the removed tumors and study whether Pioglitazone treatment can decrease the number of aggressive versus well differentiated tumors in study patients. This pilot study is designed to detect a statistically significant change in SCC tumor numbers but is not sponsored by the drug manufacturer. The data obtained will not be used to effect a change in the product label.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• >18 years of age, male or female, state of health stable

• Able understand protocol and give consent

• Has had treatment of 2 - 6 squamous cell carcinomas of the skin during the year prior to enrollment, & pathology is available for verification

• Stable treatment regimen for their skin cancer problems in place for 1 year, with expectation to keep medications the same during study

• Able to keep study appointments & comply with protocol

Exclusion Criteria:

• Unwillingness or unable to complete informed consent process

• < 18 years of age

• Allergy to Pioglitazone

• Taking Rifampin, Trimethoprim, Celebrex or Gemfibrozil

• Pregnant or breastfeeding (Pregnancy Category C)

• History of heart failure NYHA Class III or Class IV

• Subjects with type 1 or type 2 diabetes

• Problems with pedal edema

• Liver disease (ETOH, viral hepatitis, drug-induced hepatitis) or elevated ALT, AST or total bilirubin

• Osteoporosis with high risk of fracture

• History of bladder cancer

• Recent change in chronic oral medications. Participants enrolled while on a systemic medication for their skin cancer must remain on treatment.