Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109811
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2005-05-03
Brief Title:
Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of Prostate Specific Antigen Peptide 3A PSA 154-163155L NSC 722932 IND9787 With Montanide ISA-51NSC 675756 IND 9787 or Montanide ISA 51 VG NSC 737063 Vaccination in Prostate Cancer Recurrent
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase II trial is studying how well vaccine therapy works in treating patients with recurrent prostate cancer Vaccines made from peptides may help the body build an effective immune response to kill tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the T-lymphocyte immune response in patients with recurrent adenocarcinoma of the prostate treated with prostate-specific antigen PSA peptide vaccine PSA-3A PSA 154-163 155L emulsified in Montanide ISA-51
SECONDARY OBJECTIVES
I Determine the toxicity of this vaccine in these patients II Determine the effect of this vaccine on serum PSA level in these patients
OUTLINE This is a pilot study
Patients receive prostate-specific antigen PSA peptide vaccine PSA-3A PSA 154-163 155L emulsified in Montanide ISA-51 subcutaneously once in weeks 0 2 4 6 10 14 and 18 in the absence of disease progression or unacceptable toxicity
NOTE A rise in PSA alone is not considered disease progression
After completion of study treatment patients are followed at 1 and 4 weeks
I Determine the T-lymphocyte immune response in patients with recurrent adenocarcinoma of the prostate treated with prostate-specific antigen PSA peptide vaccine PSA-3A PSA 154-163 155L emulsified in Montanide ISA-51
SECONDARY OBJECTIVES
I Determine the toxicity of this vaccine in these patients II Determine the effect of this vaccine on serum PSA level in these patients
OUTLINE This is a pilot study
Patients receive prostate-specific antigen PSA peptide vaccine PSA-3A PSA 154-163 155L emulsified in Montanide ISA-51 subcutaneously once in weeks 0 2 4 6 10 14 and 18 in the absence of disease progression or unacceptable toxicity
NOTE A rise in PSA alone is not considered disease progression
After completion of study treatment patients are followed at 1 and 4 weeks
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 |
|---|---|---|---|
| CDR0000428259 | REGISTRY | PDQ Physician Data Query | None |
| GCC-0430 | None | None | None |