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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
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
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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Start Date
March 1, 2005
Primary Completion Date
September 1, 2007
Last Updated
January 23, 2013
32
ACTUAL participants
PSA:154-163(155L) peptide vaccine
BIOLOGICAL
incomplete Freund's adjuvant
BIOLOGICAL
laboratory biomarker analysis
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT01923506
NCT03689699
Data Source & Attribution
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