Activity of TroVax® Alone vs. TroVax® Plus GM-CSF in Patients With Prostate Cancer
To evaluate the efficacy and safety of Trovax and GM-CSF in patients with prostate cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- PSA response rate to TroVax® and TroVax® in combination with GM-CSF [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
- Anti-5T4 antibody levels [ Time Frame: 1st 2 cycles every 2 wks; thereafter about every 4 wks ] [ Designated as safety issue: No ]
- CD8+ve cellular response to 5T4 antigen as measured by Elispot [ Time Frame: at end of study ] [ Designated as safety issue: No ]
- Assessment of the number of adverse events and serious adverse events in both groups [ Time Frame: AEs as occur ] [ Designated as safety issue: Yes ]
- Objective response rate [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
- Overall survival of the patients [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||May 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
11 Intramuscular injection of TroVax® over 45 weeks. A single dose of 5 x 108 pfu/ml, will be given by an intramuscular injection into the deltoid muscle of the upper arm.
TroVax plus GM-CSF
11 Intramuscular injection of TroVax® over 45 weeks. A single dose of 5 x 108 pfu/ml, will be given by an intramuscular injection into the deltoid muscle of the upper arm.Drug: GM-CSF
168 subcutaneous GM-CSF injections over 45 weeks. Administered every day as a subcutaneous injection at a dose of 250mcg/m2/d (maximum 500 mcg) in weeks 1 and 2 of each 28 day cycle (total of 14 days per cycle with a total of 12 cycles).
Other Name: Leukine
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.
|United States, Texas|
|The Methodist Hospital Research Institute|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert J Amato, DO||The Methodist Hospital Research Institute|