Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108732
Status:
COMPLETED
Last Update Posted:
2015-06-30
First Post:
2005-04-18
Brief Title:
A Phase II Study of PROSTVAC-V VacciniaTRICOM and PROSTVAC-F FowlpoxTRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of PROSTVAC-V VacciniaTRICOM and PROSTVAC-F FowlpoxTRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells Biological therapies such as GM-CSF may stimulate the immune system in different ways and stop tumor cells from growing Androgens can cause the growth of prostate cancer cells Drugs such as bicalutamide and goserelin may stop the adrenal glands from making androgens in patients whose tumor cells continue to grow Giving vaccine therapy together with GM-CSF and when needed androgen ablation may be a more effective treatment for prostate cancer This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with prostate cancer that progressed after surgery andor radiation therapy
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the effect of PROSTVAC-VTRICOM Vaccinia on cycle 1 followed by PROSTVAC-FTRICOM Fowlpox and GM-CSF on biochemical PSA progression at 6 months
II To determine the change in PSA velocity pre-treatment to post-treatment
SECONDARY OBJECTIVES
I To evaluate the percentage of patients experiencing a 50 decline in serum PSA repeated at 4 weeks
II To evaluate tolerability and any toxicity related to treatment with PSA vaccine and GM-CSF
III To determine the effect of GM-CSF on PSA immediately after treatment day 4 compared to a delayed effect day 15
IV To determine the PSA nadir and percentage of patients with undetectable PSA treated with combined vaccine and androgen ablation therapy over 12 months
OUTLINE This is a multicenter study
Patients receive vaccinia-PSA-TRICOM vaccine subcutaneously SC on day 1 and sargramostim GM-CSF SC on days 1-4 during weeks 1-4 Beginning in week 5 patients receive fowlpox-PSA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4 Treatment with fowlpox-PSA-TRICOM vaccine and GM-CSF repeats every 4 weeks for 3 courses weeks 5-16 Beginning in week 17 patients receive fowlpox-PSA-TRICOM vaccine and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity
Patients with biochemical or clinical disease progression receive androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox-PSA-TRICOM vaccine and GM-CSF Treatment continues in the absence of further clinical or biochemical disease progression
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 10 years
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study within 6 months
I To evaluate the effect of PROSTVAC-VTRICOM Vaccinia on cycle 1 followed by PROSTVAC-FTRICOM Fowlpox and GM-CSF on biochemical PSA progression at 6 months
II To determine the change in PSA velocity pre-treatment to post-treatment
SECONDARY OBJECTIVES
I To evaluate the percentage of patients experiencing a 50 decline in serum PSA repeated at 4 weeks
II To evaluate tolerability and any toxicity related to treatment with PSA vaccine and GM-CSF
III To determine the effect of GM-CSF on PSA immediately after treatment day 4 compared to a delayed effect day 15
IV To determine the PSA nadir and percentage of patients with undetectable PSA treated with combined vaccine and androgen ablation therapy over 12 months
OUTLINE This is a multicenter study
Patients receive vaccinia-PSA-TRICOM vaccine subcutaneously SC on day 1 and sargramostim GM-CSF SC on days 1-4 during weeks 1-4 Beginning in week 5 patients receive fowlpox-PSA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4 Treatment with fowlpox-PSA-TRICOM vaccine and GM-CSF repeats every 4 weeks for 3 courses weeks 5-16 Beginning in week 17 patients receive fowlpox-PSA-TRICOM vaccine and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity
Patients with biochemical or clinical disease progression receive androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox-PSA-TRICOM vaccine and GM-CSF Treatment continues in the absence of further clinical or biochemical disease progression
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 10 years
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study within 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-03075 | REGISTRY | None | None |
| ECOG-E9802 | None | None | None |
| E9802 | OTHER | None | None |
| E9802 | OTHER | None | None |
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |