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GVAX®
Prostate VITAL-2
CG0070
Bladder V-0046
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Trial Name: A Phase 3 Randomized, Open-Label Study of Docetaxel in Combination with CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients with Metastatic Hormone-Refractory Prostate Cancer with Pain.
Trial #: G-0034
Objectives
• To compare the duration of survival between the two treatment arms: GVAX® immunotherapy for prostate cancer in combination with docetaxel or docetaxel plus prednisone

KEY Eligibility Criteria
• Males, greater than 18 years of age
• Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
• Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
• Detectable metastases
• ECOG performance status ≤ 2 (Performance status of 3 if due to bone pain)
• Any Gleason score
• Only one prior treatment with systemic chemotherapy
• No prior treatment with gene therapy
• Taxane-naïve
• Experiencing cancer-related pain

Treatment

Patients will be randomized to one of two treatment arms:

Arm 1: Cancer immunotherapy injections in combination with Taxotere® every 21 days over 10 cycles followed by monthly cancer immunotherapy injections alone for life or until a new treatment for prostate cancer begins.

Arm 2: Taxotere® administered every 21 days and prednisone daily for 10 cycles.


Enrollment Information

Select major eligibility criteria are listed above. For more information call 1.800.648.6747 ext. 3210. You may also check clinicaltrials.gov for a current list of locations with open sites. Continue to check this website as trial locations are being added regularly.
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