Spots Global Cancer Trial Database for Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

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Trial Identification

Brief Title: Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

Official Title: 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

Study ID: NCT00109811

Conditions

Adenocarcinoma of the Prostate

Recurrent Prostate Cancer

Interventions

PSA:154-163(155L) peptide vaccine

incomplete Freund's adjuvant

laboratory biomarker analysis

Study Description

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.