A Phase II Trial to Assess the Activity of TroVax® Alone vs. TroVax® Plus Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) in Patients With Progressive Hormone Refractory Prostate Cancer
Prostate cancer is the second leading cause of cancer death in American men. Hormonal
ablation, in the form of medical or surgical castration is the cornerstone of management for
metastatic prostate cancer however, treatment options for a patient in whom androgen
ablation fails are limited. Second-line hormonal agents are generally associated with low
response rates and no documented survival benefit.
Historically, chemotherapy was not considered to have significant activity in hormone
refractory prostate cancer (HRPCa). This view has changed within the past 10 years, partly
because of the availability of prostate-specific antigen (PSA) measurements to monitor tumor
burden. Although it seems that chemotherapy, either as a single agent or combination of
agents may lead to clinical responses, reduction in PSA measurements, pain control, or
improved quality of life, no benefit in overall survival has been definitively proven. The
current standard of care for the treatment of metastatic prostate cancer is hormone therapy
(androgen blockade).3,4 When this strategy is no longer effective, few good treatment
options are left. For this reason, prostate cancer research has aimed to identify new
therapeutic modalities to increase the impact of these parameters as well as prolong patient
survival.
A total of 24 men with prostate cancer ranging from non-metastatic rising PSA only disease
to bony metastatic disease will be enrolled in the study. All patients will have failed
androgen treatment and at least one prior taxane chemotherapy or have refused chemotherapy.
Out of the 24 patients, 12 patients will be treated using TroVax® and 12 will be treated
using TroVax® plus GM-CSF.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA response rate to TroVax® and TroVax® in combination with GM-CSF
restaging every 8 weeks
No
Robert J Amato, DO
Principal Investigator
The Methodist Hospital Research Institute
United States: Food and Drug Administration
TV/PHRPC-001/06
NCT00448409
May 2006
May 2007
Name | Location |
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The Methodist Hospital Research Institute | Houston, Texas 77030 |