VCU Massey Cancer Center and Harvard University’s Dana-Farber Cancer Institute Offer Phase I Clinical Trial for Leukemia Patients with Poor Prognosis

By Andrea Butler
Massey Cancer Center

Richmond, Va. (April 20, 2006) — The Virginia Commonwealth University Massey Cancer Center, in conjunction with Harvard University’s Dana-Farber Cancer Institute, opened a Phase I clinical trial for patients with relapsed or refractory acute leukemia; blast crisis of chronic myelogenous leukemia; or poor prognosis myelodysplatic syndrome. Refractory refers to cancer that is progressing despite chemotherapy or other forms of therapy.

Sponsored by the National Cancer Institute, the trial is the first to study the combination of two novel investigational drugs for leukemia: Vorinostat (also known as SAHA), and Flavopiridol.

Steven Grant, M.D., associate director for translational research at Massey and the principal investigator of the study, said the trial is designed for leukemia patients with a poor prognosis. ”Flavoripidol and Vorinostat, when combined, have been shown to be very effective in killing leukemia cells in the test tube, and more recently in animals,” he said. “We are now trying to determine if we can translate these promising preclinical results into the clinical arena for patients with leukemia and related hematologic disorders.”

Grant, a leading researcher in hematologic malignancies, and his team have spent the past four years investigating these two drugs in the laboratory. The Phase I trial will help to determine the appropriate doses for this combination drug therapy.

Patients who enroll in the study will be given three oral doses of Vorinostat daily for two weeks, and one intravenous infusion of Flavoripidol for approximately one hour a day for five days.

The trial may also be appropriate for patients with chronic myelogenous leukemia in blast crisis as well as certain patients with refractory anemia with an excess of blasts.

For more information on the study, contact clinical research nurse Connie Honeycutt at 804-827-1015 or choneyc@vcu.edu.