A Phase 2 Study of Prostate Specific Antigen Peptide 3A (PSA: 154-163(155L) ) (NSC # 722932, IND#9787) With Montanide ISA-51(NSC #675756, IND #9787) or Montanide® ISA 51 VG (NSC 737063) Vaccination in Prostate Cancer Recurrent
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Adenocarcinoma of the Prostate
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Change in frequency of CD8 T-lymphocyte precursors in peripheral blood mononuclear cells (PBMC), measured by ELISPOT assays
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed adenocarcinoma of the prostate
- •Must have undergone radical prostatectomy ≥ 3 months ago
- •Prostate-specific antigen (PSA) level ≥ 0.6 ng/mL and rising (after radical prostatectomy) on ≥ 2 measurements separated by ≥ 3 months
- •HLA-A2-positive peripheral blood mononuclear cells by flow cytometry
- •No clinical evidence of local recurrence
- •No palpable induration or mass in prostatic fossa
- •No metastatic prostate cancer
- •No osseous metastases by bone scan
- •Performance status - ECOG 0-1
- •Performance status - Karnofsky 70-100%
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in frequency of CD8 T-lymphocyte precursors in peripheral blood mononuclear cells (PBMC), measured by ELISPOT assays
Time Frame: From baseline to 1 week after the last dose of study treatment
A response is defined as at least a 5 fold higher frequency of INF-gamma secreting CD8 T cells after vaccination than before. A patient also will be considered a responder if no specific PSA: 154-163(155L) response was found before vaccination and a specific PSA: 154-163(155L) response is identified after vaccination.
Secondary Outcomes
- Effect of treatment on serum prostate-specific antigen level(Up to 4 weeks after completion of study treatment)
- Incidence of adverse events graded according to NCI CTCAE version 3.0(Up to 4 weeks after completion of study treatment)