Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030602
Status:
COMPLETED
Last Update Posted:
2019-11-05
First Post:
2002-02-14
Brief Title:
Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase 2 Study Of Prostate Specific Antigen-3 PSA-3 NSC 694155 With Montanide NSC 675756 Vaccination In Patients With Prostate Cancer Recurrent
Status:
COMPLETED
Status Verified Date:
2019-10
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 Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent prostate cancer
PURPOSE Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent prostate cancer
Detailed Description:
OBJECTIVES I Determine the effect of PSA-3 peptide vaccine emulsified in Montanide ISA-51 on PSA levels in patients with recurrent prostate cancer II Determine the toxicity of this regimen in these patients III Determine whether the T lymphocyte immune response to PSA-3 and HLA-A2 antigen-presenting cells that endogenously produce PSA is increased in patients treated with this regimen IV Determine the duration of the PSA andor immune responses in patients treated with this regimen V Correlate immune and PSA responses in patients treated with this regimen VI Determine the efficacy of a second boost vaccination with this regimen in patients with a PSA or immune response
OUTLINE This is a multicenter study Patients receive PSA-3 peptide vaccine emulsified in Montanide ISA-51 subcutaneously in 2 sites on days 1 8 15 and 22 in the absence of unacceptable toxicity Patients who show an immune or prostate specific antigen PSA response are followed until disease progression defined as a diminution or disappearance of an immune response or 2 consecutive increases in PSA over the nadir Patients are eligible for a second series of injections at the time of progression
PROJECTED ACCRUAL A total of 14-44 patients will be accrued for this study within 12-18 months
OUTLINE This is a multicenter study Patients receive PSA-3 peptide vaccine emulsified in Montanide ISA-51 subcutaneously in 2 sites on days 1 8 15 and 22 in the absence of unacceptable toxicity Patients who show an immune or prostate specific antigen PSA response are followed until disease progression defined as a diminution or disappearance of an immune response or 2 consecutive increases in PSA over the nadir Patients are eligible for a second series of injections at the time of progression
PROJECTED ACCRUAL A total of 14-44 patients will be accrued for this study within 12-18 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-2812 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069181 | REGISTRY | None | None |