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Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00109811
First received: May 3, 2005
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Effect of treatment on serum prostate-specific antigen level [ Time Frame: Up to 4 weeks after completion of study treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: March 2005
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 PEP VAC
  • PSA-3A
Biological: incomplete Freund's adjuvant
Given subcutaneously
Other Names:
  • IFA
  • ISA-51
  • Montanide ISA 51
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109811

Locations
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1595
Sponsors and Collaborators
Investigators
Principal Investigator: H. Richard Alexander University of Maryland Greenebaum Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00109811     History of Changes
Other Study ID Numbers: NCI-2012-02652, GCC-0430, CDR0000428259
Study First Received: May 3, 2005
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014