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Vaccine Therapy for Advanced Prostate Cancer
Untitled Document
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.
Principal Investigator
Dr. Philip Arlen, NCI Center for Cancer Research.
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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 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.
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