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
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.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in frequency of CD8 T-lymphocyte precursors in peripheral blood mononuclear cells (PBMC), measured by ELISPOT assays
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.
From baseline to 1 week after the last dose of study treatment
H. Richard Alexander
University of Maryland Greenebaum Cancer Center
United States: Food and Drug Administration
|University of Maryland Greenebaum Cancer Center||Baltimore, Maryland 21201|