NCT00109811

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

2.5 years

First QC Date

May 3, 2005

Last Update Submit

January 22, 2013

Conditions

Adenocarcinoma of the ProstateRecurrent Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in frequency of CD8 T-lymphocyte precursors in peripheral blood mononuclear cells (PBMC), measured by ELISPOT assays

    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 Outcomes (2)

  • Effect of treatment on serum prostate-specific antigen level

    Up to 4 weeks after completion of study treatment

  • Incidence of adverse events graded according to NCI CTCAE version 3.0

    Up to 4 weeks after completion of study treatment

Study Arms (1)

Treatment

EXPERIMENTAL

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 vaccineBiological: incomplete Freund's adjuvantOther: laboratory biomarker analysis

Interventions

PSA:154-163(155L) peptide vaccineBIOLOGICAL

Given subcutaneously

Also known as: PSA PEP VAC, PSA-3A
Treatment
incomplete Freund's adjuvantBIOLOGICAL

Given subcutaneously

Also known as: IFA, ISA-51, Montanide ISA 51
Treatment
laboratory biomarker analysisOTHER

Correlative studies

Treatment

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201-1595, United States

Location

Related Publications (1)

  • 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.

    PMID: 19483644DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

prostate-specific antigen (154-163)Protein Subunit Vaccinesincomplete Freund's adjuvantmontanide ISA 51

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Vaccines, AcellularVaccines, SubunitVaccinesBiological ProductsComplex Mixtures

Study Officials

  • H. Richard Alexander

    University of Maryland Greenebaum Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2005

First Posted

May 4, 2005

Study Start

March 1, 2005

Primary Completion

September 1, 2007

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(1)