Name of the Trial
Phase II Chemoprevention Study of Pioglitazone in Patients with Hyperplastic or Dysplastic Oral Cavity or Oropharyngeal Leukoplakia (UMN-0109M07254). See the protocol summary at http://cancer.gov/clinicaltrials/UMN-0109M07254.

Principal Investigator
Dr. Frank Ondrey, University of Minnesota Cancer Center

Why Is This Trial Important?
Head and neck cancer affects over 38,000 Americans each year, resulting in 11,000 deaths. Head and neck cancer sites are divided into the oral cavity, the oropharynx, and the larynx (voice box) and related structures. The oral cavity includes the lips and most of the soft tissue inside the mouth (for example, the gums and the main part of the tongue). The oropharynx includes the soft palate at the back of the mouth, the tonsils, and the base of the tongue. The larynx includes the voice box area and the entry tissues into the esophagus.

Leukoplakia, an abnormal patch of white tissue that forms on mucous membranes inside the mouth and elsewhere in the body, may be a precursor to head and neck cancer.

In this study, researchers are investigating the ability of pioglitazone, a drug used to treat type II diabetes, to reverse leukoplakia and prevent it from developing into head and neck cancer. Pioglitazone belongs to a new class of oral antidiabetic drugs called thiazolidinediones that have been shown to inhibit growth of some epithelial cancer cells.

"There is no current standard for screening or treatment of leukoplakia like there is for precancerous lesions of the colon, for example," said Dr. Ondrey. "We know that over the course of 5 years about 5 percent of patients with oral leukoplakia will develop invasive cancer, so it is important that we develop an effective means of treating the condition and preventing it from progressing to cancer."

Who Can Join This Trial?
Researchers seek to enroll up to 33 patients diagnosed with hyperplastic or dysplastic oral cavity or oropharyngeal leukoplakia. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/UMN-0109M07254.

Where Is This Trial Taking Place?
This trial is being conducted at the University of Minnesota Cancer Center in Minneapolis.

Contact Information
For more information, call the University of Minnesota Cancer Center at 612-624-2620 or NCI's Cancer Information Service toll-free at 1-800-4-CANCER (1-800-422-6237). The call is completely confidential.

An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.