Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer
|Adenocarcinoma of the Prostate Recurrent Prostate Cancer||Biological: PSA:154-163(155L) peptide vaccine Biological: incomplete Freund's adjuvant Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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.
- Effect of treatment on serum prostate-specific antigen level [ Time Frame: Up to 4 weeks after completion of study treatment ]The PSA reduction is defined as is at least 50% fall in the serum PSA level after vaccination. The proportion of patients who showed a reduction in serum PSA will be estimated and corresponding 95% confidence intervals will be calculated.
- Incidence of adverse events graded according to NCI CTCAE version 3.0 [ Time Frame: Up to 4 weeks after completion of study treatment ]
|Study Start Date:||March 2005|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Patients receive 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.
Biological: PSA:154-163(155L) peptide vaccine
Other Names:Biological: incomplete Freund's adjuvant
Other Names:Other: laboratory biomarker analysis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109811
|United States, Maryland|
|University of Maryland Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201-1595|
|Principal Investigator:||H. Richard Alexander||University of Maryland Greenebaum Cancer Center|