Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

January 22, 2013 updated by: National Cancer Institute (NCI)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201-1595
        • University of Maryland Greenebaum Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: laboratory biomarker analysis
Correlative studies
Biological: incomplete Freund's adjuvant
Given subcutaneously
Other Names:
  • IFA
  • ISA-51
  • Montanide ISA 51
Biological: PSA:154-163(155L) peptide vaccine
Given subcutaneously
Other Names:
  • PSA PEP VAC
  • PSA-3A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to 1 week after the last dose of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 4 weeks after completion of study treatment
Incidence of adverse events graded according to NCI CTCAE version 3.0
Time Frame: Up to 4 weeks after completion of study treatment
Up to 4 weeks after completion of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: H. Richard Alexander, University of Maryland Greenebaum Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

May 3, 2005

First Submitted That Met QC Criteria

May 3, 2005

First Posted (Estimate)

May 4, 2005

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02652
  • GCC-0430
  • CDR0000428259 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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