DFMO IN PHASE I NCI CANCER CHEMOPREVENTION TRIALS

Executive Summary

DFMO IN PHASE I NCI CANCER CHEMOPREVENTION TRIALS are under way at Roswell Park Hospital in Buffalo, N.Y. The National Cancer Institute is sponsoring the study to look at the effect of eflornithine (DFMO) use in "higher than normal risk" patients who still have polyps and are post-resection for breast cancer and other carcinomas. The six-month study is set to include 25 patients; 20 patients are currently receiving the drug. The immediate endpoint of the study is the presence of polymene pools in the red blood cells and their relationship to toxicity. Biochemical changes associated with cancer are known to decrease in pools of polymenes. Marion Merrell Dow is developing the anti-protozoale/anti-prypanosomal agent under the brand name Ornidyl (eflornithine). The company filed an NDA in August 1988 for an orphan indication in the treatment of African sleeping sickness. In addition, the company is reportedly conducting Phase III trials for an orphan indication in the treatment of Pneumocystis carinii pneumonia (PCP) infections related to AIDS. Marion Merrell Dow reportedly is not involved in the Roswell Park chemoprevention work. Roswell Park is planning another NCI-sponsored cancer chemoprevention trial in early 1991 to test N-acetylcysteine . This study looks to measure the ability of the drug to affect intracellular, sulfidial-containing compounds such as plutothyone. The study design will be similar to the DFMO trial, enrolling 20 to 25 patients to receive daily oral administration that will increase in the absence of toxicity.