Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045227
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2002-09-06
Brief Title:
Vaccine Therapy With or Without Docetaxel in Treating Patients With Metastatic Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Trial of Pox Vector PSA Vaccine With Concurrent Docetaxel Versus Pox Vector Vaccine Followed by Docetaxel in Metastatic Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2003-12
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:
RATIONALE Vaccines may make the body build an immune response to kill tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining vaccine therapy with chemotherapy may kill more tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of vaccine therapy with or without docetaxel in treating patients who have metastatic prostate cancer
PURPOSE Randomized phase II trial to compare the effectiveness of vaccine therapy with or without docetaxel in treating patients who have metastatic prostate cancer
Detailed Description:
OBJECTIVES
Compare the relative change in prostate-specific antigen PSA-specific T-cell precursors CD8 from baseline to day 85 in patients with metastatic androgen-independent prostate cancer treated with a vaccination regimen comprising fowlpox-PSA vaccine recombinant rV-B71 vaccine recombinant vaccinia-PSA vaccine and sargramostim GM-CSF with or without docetaxel
Compare the safety of these regimens in these patients
Compare clinical activity of these regimens in these patients
Determine the immunologic effects in these patients after additional vaccinechemotherapy courses
Measure CD4 T-cell responses to the vaccine in these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms after receiving priming vaccinations
Priming vaccinations All patients receive recombinant vaccinia-prostate-specific antigen PSA vaccine subcutaneously SC and recombinant rV-B71 vaccine SC on day 1 and sargramostim GM-CSF SC on days 1-4 Patients then receive fowlpox-PSA vaccine F-PSA SC on day 15 and GM-CSF SC on days 15-18
Arm I Patients receive docetaxel IV over 30 minutes on days 29 36 and 43 F-PSA SC on day 30 and GM-CSF SC on days 30-33 Treatment repeats beginning on day 56 for one more course Patients who do not have disease progression at day 85 receive docetaxel weekly for 3 weeks and F-PSA on day 1 of each course Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients receive F-PSA SC on days 29 and 57 and GM-CSF SC on days 29-32 and 57-60 Patients who show disease progression after day 85 either radiographically or by rising PSA stop receiving the vaccine and may receive docetaxel weekly for 3 weeks Chemotherapy repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 28 patients 14 per treatment arm will be accrued for this study within 9-10 months
Compare the relative change in prostate-specific antigen PSA-specific T-cell precursors CD8 from baseline to day 85 in patients with metastatic androgen-independent prostate cancer treated with a vaccination regimen comprising fowlpox-PSA vaccine recombinant rV-B71 vaccine recombinant vaccinia-PSA vaccine and sargramostim GM-CSF with or without docetaxel
Compare the safety of these regimens in these patients
Compare clinical activity of these regimens in these patients
Determine the immunologic effects in these patients after additional vaccinechemotherapy courses
Measure CD4 T-cell responses to the vaccine in these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms after receiving priming vaccinations
Priming vaccinations All patients receive recombinant vaccinia-prostate-specific antigen PSA vaccine subcutaneously SC and recombinant rV-B71 vaccine SC on day 1 and sargramostim GM-CSF SC on days 1-4 Patients then receive fowlpox-PSA vaccine F-PSA SC on day 15 and GM-CSF SC on days 15-18
Arm I Patients receive docetaxel IV over 30 minutes on days 29 36 and 43 F-PSA SC on day 30 and GM-CSF SC on days 30-33 Treatment repeats beginning on day 56 for one more course Patients who do not have disease progression at day 85 receive docetaxel weekly for 3 weeks and F-PSA on day 1 of each course Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients receive F-PSA SC on days 29 and 57 and GM-CSF SC on days 29-32 and 57-60 Patients who show disease progression after day 85 either radiographically or by rising PSA stop receiving the vaccine and may receive docetaxel weekly for 3 weeks Chemotherapy repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 28 patients 14 per treatment arm will be accrued for this study within 9-10 months
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-02-C-0218 | None | None | None |
| NCI-5319 | None | None | None |