Name of the Trial
Phase I/II Randomized Pilot Study of Sequential Vaccination with Vaccinia-PSA-TRICOM Vaccine and Fowlpox PSA TRICOM Vaccine with or without Sargramostim (GM-CSF), or Fowlpox-GM-CSF in Patients with Metastatic Prostate Cancer (NCI-03-C-0176). See the protocol summary at http://cancer.gov/clinicaltrials/ NCI-03-C-0176.

Principal Investigator
Dr. Philip Arlen, NCI Center for Cancer Research

Why Is This Trial Important?
Prostate cancer, the second leading cause of cancer death in American men, recurs in 30 to 40 percent of patients despite advances in early detection and treatment. Patients with advanced or recurrent prostate cancer often are treated with hormonal therapies, which are designed to slow tumor growth by reducing levels of male hormones in the body. Resistance to hormonal therapies eventually develops in almost all patients with prostate cancer that has recurred or spread (metastasized).

The lack of effective therapies for metastatic or recurrent prostate cancer has inspired researchers to begin exploring new approaches that precisely target prostate cancer cells. Vaccine-based immunotherapy, which stimulates the immune system to attack cancer cells, represents a particularly promising approach. The researchers conducting this trial have developed a comprehensive vaccine- based immunotherapy regimen that targets prostate-specific antigen (PSA), a protein made by both normal and cancerous epithelial cells of the prostate. Men with prostate cancer often have elevated PSA levels in their blood, and PSA levels are thought to indicate the amount of prostate cancer in the body.

"What is most exciting about this study is that we are looking at the safety and effectiveness of third-generation vaccines with dramatically increased potency," said Dr. Arlen. "If the results prove positive, we will undertake additional studies to assess their effectiveness when combined with other forms of treatment."

Who Can Join This Trial?
Accrual for phase I has been completed. For the phase II part of the trial, researchers seek to enroll 32 patients with confirmed metastatic prostate cancer that is unresponsive to hormone therapy. See the complete list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-03-C-0176.

Where Is This Trial Taking Place?
The study is taking place at the NIH Clinical Center in Bethesda, Maryland.

Contact Information
Contact the NCI Clinical Studies Support Center at 1-888-NCI-1937. The call is toll-free and confidential.

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