Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia

Launched by UNIVERSITY OF MINNESOTA · Feb 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two medications, pioglitazone and metformin, to see if they can help treat oral leukoplakia, a condition where white patches form in the mouth that could lead to cancer. The trial will last 12 weeks, and participants will take the medications twice a day. The main goal is to find out if these medications can reduce the severity of the leukoplakia in more than half of the participants and to see if there are any improvements in the tissue samples taken from their lesions.

To be eligible for this study, participants must be at least 18 years old and have certain types of oral leukoplakia that can be measured. They should also be in good health and able to swallow tablets. However, individuals who are pregnant, have uncontrolled diabetes, or have certain types of cancer within the last 18 months cannot join. Those who participate can expect regular check-ins and evaluations to track their progress and any changes in their condition throughout the trial. This research is important because it may lead to new treatment options for people at high risk of developing oral cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Biopsy proven hyperplasia in high risk anatomic areas (floor of mouth, mobile tongue, oropharynx). Hyperplasia or dysplasia of any grade in any erythroplakia lesion. Mild, moderate or severe dysplasia within the lesion at any site of the oral cavity or oropharynx.
• • Must have objective evidence of oral leukoplakia that is measurable in 2 dimensions per RECIST. The lesion(s) may be clinically characterized by leukoplakia, erythroplakia, erythro/leukoplakia. Lesions may be located in the oral cavity or oropharynx. However, the index lesion must be located in an anatomic site accessible by punch biopsy and be a minimum of 4mm x 8 mm to permit a 4mm punch biopsy.
• • Age 18 years or older at the time of consent.
• • Evidence of adequate organ function within 14 days prior to Day 1
• • Able to comply with treatment (i.e. able to swallow a tablet whole, not crushed) and complete a 12 week course of twice daily medication as required by this study in the opinion of the treating investigator.
• • Body mass index (BMI) is ≥ 18.5.
• • Sexually active persons of child-bearing potential agrees to use adequate contraception (a hormonal method that has been in continual use for a minimum of 3 months prior to the study screening visit, a barrier method, or abstinence) for the duration of study participation.
• • Provides voluntary written consent prior to the performance of any research related activity.
• Exclusion Criteria:
• • Pregnant or breastfeeding or planning to become pregnant.
• • A concurrent diagnosis of Type I or Type II diabetes that is being treated with insulin or an antidiabetic agent. Participants whose Type II diabetes is controlled with diet and/or exercise alone are eligible provided they meet all other eligibility criteria.
• • Participant is taking another investigational agent (not approved by the FDA for any indication).
• • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ACTOplus Met, pioglitazone or metformin.
• • Any contraindication to biopsy - this study requires a 4 mm punch biopsy of a lesion and of nearby normal tissue prior to treatment and at the end of the 12 week treatment period.
• • History of bladder cancer, including in situ bladder cancer.
• • History of invasive cancer (other than non-melanoma skin cancer or cervical cancer in situ) active within 18 months prior to the baseline study visit. (Participants who have a history of cancer that was curatively treated without evidence of recurrence in the 18 months prior to the baseline study visit are considered eligible).