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Name of the Trial

Phase I Pilot Study of Vaccine Therapy Comprising Priming Vaccinations of Vaccinia-PSA-TRICOM and Recombinant Fowlpox GM-CSF (rF-GM-CSF) Followed By Boosting Vaccinations of Fowlpox-PSA-TRICOM With or Without rF-GM-CSF in Patients With Progressive or Locally Recurrent Prostate Cancer (NCI-05-C-0017). See the protocol summary ³.

Principal Investigator

Dr. James Gulley Principal Investigator

Dr. James Gulley, NCI Center for Cancer Research.

Why This Trial Is Important

Excluding non-melanoma skin cancers, prostate cancer is the most common cancer - and the third most deadly - among North American men. Despite advances in early detection and treatment, the disease recurs in 30 to 40 percent of patients. Although several treatment options exist for recurrent disease, there is no consensus on which is best and additional treatment options are needed.

Prostate-specific antigen (PSA), a protein made by the prostate gland, is often overproduced in prostate cancer. Several studies have shown that PSA-containing vaccines can stimulate the immune system to produce T lymphocytes capable of killing prostate cancer cells. Moreover, some studies in mice suggest that injecting vaccines directly into tumors dramatically boosts the immune response, killing more tumor cells.

In this study, researchers are testing this approach in patients with prostate cancer that has recurred locally or progressed following previous treatment. Besides PSA, the vaccines they are using contain T-cell costimulatory molecules to further boost the body's immune response.

"We believe that by placing the vaccine directly into the tumor, the resulting increase in local immune activation will be like shining a laser on the tumor, making it a better target for the T cells," says Dr. Gulley.

Who Can Join This Trial

Researchers seek to enroll up to 30 men aged 18 or over with prostate cancer that has recurred locally after previous radiotherapy or cryotherapy or has progressed despite androgen deprivation therapy. See the list of eligibility criteria ⁴.

Study Site and Contact Information

This study is taking place at the NIH Clinical Center in Bethesda, Md. For more information, call the NCI Clinical Studies Support Center (CSSC) toll free at 1-888-NCI-1937. The call is confidential.

Glossary Terms

Treatment to suppress or block the production or action of male hormones. This is done by having the testicles removed, by taking female sex hormones, or by taking drugs called antiandrogens. Also called androgen ablation and androgen deprivation.

Any method that uses cold temperature to treat disease.

The activity of the immune system against foreign substances (antigens).

A protein made by the prostate gland and found in the blood. Prostate-specific antigen blood levels may be higher than normal in men who have prostate cancer, benign prostatic hyperplasia (BPH), or infection or inflammation of the prostate gland. Also called PSA.

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiotherapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiation therapy.