Clinical Trials Directory

Trials / Completed

CompletedNCT00109811

Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
32 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPSA:154-163(155L) peptide vaccineGiven subcutaneously
BIOLOGICALincomplete Freund's adjuvantGiven subcutaneously
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2005-03-01
Primary completion
2007-09-01
First posted
2005-05-04
Last updated
2013-01-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00109811. Inclusion in this directory is not an endorsement.