Emory University's Winship Cancer Institute has opened a new Phase 3 clinical trial that is utilizing a promising vaccine against prostate cancer. The trial, which is sponsored by Cell Genesys, Inc., compares the GVAX prostate cancer vaccine with docetaxel chemotheraphy, which is standard treatment for patients with hormone refractory prostate cancer, or prostate cancer that is resistant to treatment.
GVAX prostate cancer vaccine is currently in Phase 3 clinical development for patients with advanced-stage, hormone-refractory prostate cancer. The vaccine is comprised of two prostate cancer cell lines that have been genetically modified to secrete granulocyte-macrophage colony stimulating factor (GM-CSF), a hormone that plays a key role in stimulating the body's immune response to vaccines, and then irradiated for safety.
"This clinical trial is an important step in development of this new vaccine," said Vasily Assikis, MD, Assistant Professor of Hematology and Oncology, and Director of the Winship Cancer Institute Prostate Cancer Translational Research Program. Dr. Assikis is principle investigator on the clinical trial at Winship. "It is a multi-site trial that is being conducted throughout the United States."
"GVAX prostate cancer vaccine is designed to stimulate a systemic immune response against the patient's prostate cancer, destroying prostate cancer cells that persist or recur following surgery, hormone or radiation therapy," said Dr. Assikis.
According to the American Cancer Society, nearly 200,000 men in the United States will be newly diagnosed with prostate cancer. It is the second-leading cause of cancer death in men, after lung cancer. The two methods that are currently used to treat prostate cancer are radiation therapy and surgery. Radiation therapy has proven to be only partially effective and surgery must be done delicately due to the intricate network of blood vessels in the area surrounding the prostate.
Eligibility for this trial includes the following:
* Diagnosis or history of prostate cancer
* Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
* Presence of detectable metastases on bone scan or cat scan
* Any Gleason score
* ECOG performance status 0-2
* No prior treatment with chemotherapy
* No significant cancer related pain.
Patients will be enrolled in one of two treatment arms. Patients randomized to Arm 1 will receive an initial vaccination of GVAX® followed 14 days later by boost vaccinations every 14 days for 12 treatments for a total of 13 vaccinations (24 weeks of treatment).
Patients randomized to Arm 2 will receive Taxotere® (docetaxel) and prednisone every 21 days for up to 9 cycles (24 weeks of treatment).The duration of the study treatment is approximately 6 months. Additional visits at 6 and 12 months will occur following treatment. Patients will then be followed for the duration of their life for survival/long-term follow-up.
For more information about this clinical trial, please contact: Edith Woodward, 404-778-5848, or via e-mail at firstname.lastname@example.org.