Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00109811
Recruitment Status : Completed
First Posted : May 4, 2005
Last Update Posted : January 23, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

May 3, 2005
May 4, 2005
January 23, 2013
March 2005
September 2007   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00109811 on Archive Site
  • 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 ]
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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
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


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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Adenocarcinoma of the Prostate
  • Recurrent Prostate Cancer
  • Biological: PSA:154-163(155L) peptide vaccine
    Given subcutaneously
    Other Names:
    • PSA-3A
  • Biological: incomplete Freund's adjuvant
    Given subcutaneously
    Other Names:
    • IFA
    • ISA-51
    • Montanide ISA 51
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment
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
  • Biological: incomplete Freund's adjuvant
  • Other: laboratory biomarker analysis
Kouiavskaia DV, Berard CA, Datena E, Hussain A, Dawson N, Klyushnenkova EN, Alexander RB. Vaccination with agonist peptide PSA: 154-163 (155L) derived from prostate specific antigen induced CD8 T-cell response to the native peptide PSA: 154-163 but failed to induce the reactivity against tumor targets expressing PSA: a phase 2 study in patients with recurrent prostate cancer. J Immunother. 2009 Jul-Aug;32(6):655-66. doi: 10.1097/CJI.0b013e3181a80e0d.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Must have undergone radical prostatectomy ≥ 3 months ago
  • Prostate-specific antigen (PSA) level ≥ 0.6 ng/mL and rising (after radical prostatectomy) on ≥ 2 measurements separated by ≥ 3 months
  • HLA-A2-positive peripheral blood mononuclear cells by flow cytometry
  • No clinical evidence of local recurrence

    • No palpable induration or mass in prostatic fossa
  • No metastatic prostate cancer

    • No osseous metastases by bone scan
  • Performance status - ECOG 0-1
  • Performance status - Karnofsky 70-100%
  • More than 1 year
  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Bilirubin normal
  • Hepatitis B and C negative
  • Creatinine normal
  • Creatinine clearance ≥ 60 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study PSA peptide vaccine or Montanide ISA-51
  • No history of systemic autoimmune disease or autoimmune disease requiring anti-inflammatory or immunosuppressive therapy

    • Patients with history of autoimmune thyroiditis are eligible provided the patient requires only thyroid hormone replacement therapy AND disease has been stable for ≥ 1 year
  • No known HIV positivity
  • No ongoing or active infection
  • No primary or secondary immune deficiency
  • No psychiatric illness or social situation that would preclude study compliance
  • No history of other uncontrolled illness
  • No prior chemotherapy
  • No prior hormonal therapy
  • No concurrent systemic or ocular steroid therapy, except for any of the following:

    • Inhaled steroids for asthma
    • Limited topical steroids
    • Replacement doses of cortisone
  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to the prostate

    • Prior radiotherapy to the pelvis after radical prostatectomy allowed
  • See Disease Characteristics
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000428259 ( Registry Identifier: PDQ (Physician Data Query) )
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National Cancer Institute (NCI)
National Cancer Institute (NCI)
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Principal Investigator: H. Richard Alexander University of Maryland Greenebaum Cancer Center
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP