Clinical trial targets advanced prostate cancer

December 3, 2012

Select patients with advanced prostate cancer may benefit from a Georgia Health Sciences University Cancer Center clinical trial that looks to improve survival rates of the FDA-approved prostate cancer drug Provenge.

The trial, led by GHSU Cancer Center Director Samir N. Khleif, is the first in the country to investigate combining Provenge with two other cancer-fighting drugs, CT-011 and cyclophosphamide. As the first FDA-approved immunotherapy treatment for prostate cancer, Provenge has been found to extend life expectancy of certain men with advanced prostate cancer by nearly 20 percent.

"Although the increased overall survival seen with Provenge treatment is a welcome advance in the treatment of prostate cancer, the goal of cancer therapy must be the eradication of disease," said Khleif. "Therefore, improvements can be made, and this clinical trial is intended to improve the current standard of care."

Provenge works by training the body's immune system to find and attack . Khleif's trial hopes to boost Provenge's effectiveness by combining it with two other drugs: CT-011, a type of antibody that reverses caused by cancer, and cyclophosphamide, which in a low dose enhances the effect of Provenge and CT-011. Both have been safely used alone or in combination with other cancer therapies, but never for prostate cancer.

Preclinical animal studies in Khleif's lab found that the combination of Provenge with these two other drugs led to a significant increase in survival and complete in more than 50 percent of mice. Based on these results, Dendreon Corporation, the makers of Provenge, and Khleif are collaborating on this first in human trial.

Khleif joined the GHSU Cancer Center as its Director after more than 22 years in the Section at the . His lab focuses on research into vaccines to help the immune system target and eradicate cancers.

Prostate cancer is the most common cancer and the second leading cause of cancer deaths among men in most Western countries.

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