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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 ³.

Principal Investigator

Dr. Philip Arlen, NCI Center for Cancer Research.

Dr. Philip Arlen Principal Investigator

Why This Trial is 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 are often 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."

Contact Information

This clinical trial is no longer accepting new patients. To locate other clinical trials for prostate cancer, search the NCI's database of clinical trials ¹ or contact the NCI Clinical Studies Support Center at 1-888-NCI-1937. The call is toll-free and confidential.

Published Results

Arlen PM, Gulley J, Dahut W, et al.: A phase I study of sequential vaccinations with recombinant Fowlpox-PSA (L155)-TRICOM (rF) alone, or in combination with recombinant vaccinia-PSA (L155)-TRICOM (rV), and the role of GM-CSF, in patients (Pts) with prostate cancer. [Abstract] J Clin Oncol 22 (Suppl 14): A-2522, 168s, 2004.

Glossary Terms

Treatment that adds, blocks, or removes hormones. For certain conditions (such as diabetes or menopause), hormones are given to adjust low hormone levels. To slow or stop the growth of certain cancers (such as prostate and breast cancer), synthetic hormones or other drugs may be given to block the body’s natural hormones. Sometimes surgery is needed to remove the gland that makes a certain hormone. Also called endocrine therapy, hormone therapy, and hormone treatment.

A molecule made up of amino acids that are needed for the body to function properly. Proteins are the basis of body structures such as skin and hair and of substances such as enzymes, cytokines, and antibodies.

Cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body. Also called recurrence.