Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003871
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
PSA Vaccine Therapy in Treating Patients With Advanced Prostate Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Randomized Study of Vaccine Treatment of Advanced Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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
PURPOSE Randomized phase II trial to study the effectiveness of different regimens of PSA vaccines in treating patients who have advanced prostate cancer
PURPOSE Randomized phase II trial to study the effectiveness of different regimens of PSA vaccines in treating patients who have advanced prostate cancer
Detailed Description:
OBJECTIVES I Evaluate the effect of prime and boost strategies using recombinant fowlpox prostate specific antigen PSA vaccine and recombinant vaccinia PSA vaccine on biochemical PSA progression in patients with stage D0 prostate cancer who have completed local treatment II Assess the tolerability and toxicity of these prime and boost treatment regimens in these patients III Evaluate the effects of these prime and boost treatment regimens on cellular immunity in these patients
OUTLINE This is a randomized study Patients are stratified according to HLA-2 typing positive vs negative vs unknown Patients are randomized to one of three treatment arms Arm I Patients receive intramuscular fowlpox prostate specific antigen PSA vaccine at weeks 0 6 12 and 18 Arm II Patients receive intramuscular fowlpox PSA vaccine at weeks 0 6 and 12 and intradermal vaccinia PSA vaccine at week 18 Arm III Patients receive intradermal vaccinia PSA vaccine at week 0 and intramuscular fowlpox PSA vaccine at weeks 6 12 and 18 Patients are followed at week 24 then every 3 months until year 2 every 6 months until year 5 and annually thereafter
PROJECTED ACCRUAL A total of 60 patients 20 per treatment arm will be accrued for this study
OUTLINE This is a randomized study Patients are stratified according to HLA-2 typing positive vs negative vs unknown Patients are randomized to one of three treatment arms Arm I Patients receive intramuscular fowlpox prostate specific antigen PSA vaccine at weeks 0 6 12 and 18 Arm II Patients receive intramuscular fowlpox PSA vaccine at weeks 0 6 and 12 and intradermal vaccinia PSA vaccine at week 18 Arm III Patients receive intradermal vaccinia PSA vaccine at week 0 and intramuscular fowlpox PSA vaccine at weeks 6 12 and 18 Patients are followed at week 24 then every 3 months until year 2 every 6 months until year 5 and annually thereafter
PROJECTED ACCRUAL A total of 60 patients 20 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| E-7897 | None | None | None |