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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)

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

Condition or disease Intervention/treatment Phase
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

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2005
Actual Primary Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Incidence of adverse events graded according to NCI CTCAE version 3.0 [ Time Frame: Up to 4 weeks after completion of study treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00109811

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United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1595
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: H. Richard Alexander University of Maryland Greenebaum Cancer Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00109811     History of Changes
Other Study ID Numbers: NCI-2012-02652
CDR0000428259 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 4, 2005    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Freund's Adjuvant
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic