Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020254
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Vaccine Therapy Plus Sargramostim and Interleukin-2 Compared With Nilutamide Alone in Treating Patients With Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Study of Either Immunotherapy With a Regimen of Recombinant Pox Viruses That Express PSAB71 Plus Adjuvant GM-CSF and IL2 or Hormone Therapy With Nilutamide in Patients With Hormone Refractory Prostate Cancer and No Radiographic Evidence of Disease
Status:
COMPLETED
Status Verified Date:
2003-04
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:
RATIONALE Vaccines made from prostate cancer cells may make the body build an immune response to kill tumor cells Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood Interleukin-2 may stimulate a persons white blood cells to kill prostate cancer cells Androgens can stimulate the growth of prostate cancer cells Hormone therapy using nilutamide may fight prostate cancer by reducing the production of androgens It is not yet known which treatment regimen is more effective for treating prostate cancer
PURPOSE Randomized phase II trial to compare the effectiveness of vaccine therapy plus sargramostim and interleukin-2 with that of nilutamide alone in treating patients who have prostate cancer that has not responded to hormone therapy
PURPOSE Randomized phase II trial to compare the effectiveness of vaccine therapy plus sargramostim and interleukin-2 with that of nilutamide alone in treating patients who have prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES
Compare the difference in time to radiographic evidence of disease progression at 6 months in patients with hormone-refractory prostate cancer when treated with vaccine containing recombinant vaccinia-prostate-specific antigen PSA admixed with rV-B71 plus recombinant fowlpox-PSA vaccine sargramostim GM-CSF and interleukin-2 vs nilutamide alone
Evaluate the vaccination therapy in relation to the change in T-cell precursor frequency and to the rise of serum PSA in this patient population
OUTLINE This is a randomized study Patients are stratified according to HLA-A2 typing positive vs negative Patients are randomized to one of two treatment arms
Arm I Patients receive vaccine containing recombinant vaccinia-prostate-specific antigen PSA and rV-B71 subcutaneously SC on day 2 only Beginning on day 30 patients receive recombinant fowlpox-PSA vaccine SC every 4 weeks for 12 vaccinations and then every 12 weeks thereafter Patients also receive sargramostim GM-CSF SC daily on days 1-4 and interleukin-2 SC daily on days 8-12 with each vaccination
Patients without disease progression after 12 courses receive the vaccine regimen every 12 weeks
Arm II Patients receive oral nilutamide daily Treatment continues in both arms for at least 6 months in the absence of disease progression or unacceptable toxicity
After 6 months of therapy patients with a rising PSA and no radiographic evidence of disease progression may receive therapy in the other arm in addition to the therapy to which they were randomized
Patients are followed monthly for 6 months and then every 2 months thereafter
PROJECTED ACCRUAL A total of 56-78 patients 28-39 per treatment arm will be accrued for this study within 15-2 years
Compare the difference in time to radiographic evidence of disease progression at 6 months in patients with hormone-refractory prostate cancer when treated with vaccine containing recombinant vaccinia-prostate-specific antigen PSA admixed with rV-B71 plus recombinant fowlpox-PSA vaccine sargramostim GM-CSF and interleukin-2 vs nilutamide alone
Evaluate the vaccination therapy in relation to the change in T-cell precursor frequency and to the rise of serum PSA in this patient population
OUTLINE This is a randomized study Patients are stratified according to HLA-A2 typing positive vs negative Patients are randomized to one of two treatment arms
Arm I Patients receive vaccine containing recombinant vaccinia-prostate-specific antigen PSA and rV-B71 subcutaneously SC on day 2 only Beginning on day 30 patients receive recombinant fowlpox-PSA vaccine SC every 4 weeks for 12 vaccinations and then every 12 weeks thereafter Patients also receive sargramostim GM-CSF SC daily on days 1-4 and interleukin-2 SC daily on days 8-12 with each vaccination
Patients without disease progression after 12 courses receive the vaccine regimen every 12 weeks
Arm II Patients receive oral nilutamide daily Treatment continues in both arms for at least 6 months in the absence of disease progression or unacceptable toxicity
After 6 months of therapy patients with a rising PSA and no radiographic evidence of disease progression may receive therapy in the other arm in addition to the therapy to which they were randomized
Patients are followed monthly for 6 months and then every 2 months thereafter
PROJECTED ACCRUAL A total of 56-78 patients 28-39 per treatment arm will be accrued for this study within 15-2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T99-0097 | None | None | None |
| NCI-00-C-0137 | None | None | None |
| MB-NAVY-99-04 | None | None | None |