Vaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer

November 5, 2012 updated by: Teresa Hayes, Baylor College of Medicine

Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14)

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects of a peptide vaccine in treating patients with metastatic prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Evaluate the safety and tolerance of NY-ESO-1/LAGE-1 class-I and class-II vaccine administered subcutaneously in patients with androgen-independent metastatic prostate cancer.

Secondary

  • Compare the response induced by immunotherapy with a combined class-I and class-II NY-ESO-1/LAGE-1 vaccine to responses obtained to either class I or class II peptides alone.
  • Evaluate whether the inclusion of class-II epitopes in a peptide vaccine will result in a better antitumor immune response than class-I epitopes alone.
  • Determine antitumor activity by antigen response assays including cytokine elaboration, changes in frequency of peripheral T cells that recognize tumor, and intra/peritumoral cellular infiltrates and cytokine expression in responding and nonresponding metastasis.

OUTLINE: Patients receive NY-ESO-1/LAGE-1 peptide vaccine subcutaneously every other week for 12 weeks in the absence of disease progression or unacceptable toxicity. The initial cohorts of patients are treated with one course of either MHC Class I-binding or MHC Class II-binding peptides. If these Class I or Class II binding peptides are safe individually, subsequent cohorts of patients with appropriate HLA type receive both types of peptides in combination.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

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
    • Texas
      • Houston, Texas, United States, 77030
        • Dan L. Duncan Cancer Center at Baylor College of Medicine

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer with evidence of progressive disease despite hormonal therapy (i.e., hormone-refractory prostate cancer)

    • Metastatic disease

    • Progressive disease defined by any of the following:

      • New bone lesion on bone scan
      • Progression of nodal or soft tissue as evidenced by standard radiographic methods, i.e., CT scan or MRI
      • A 50% increase in PSA level from the nadir PSA level confirmed twice and measured at least 2 weeks apart, with stable and measurable disease
  • Castrate serum levels of testosterone < 50 ng/dL

  • If patient was receiving anti-androgen therapy, in addition to luteinizing hormone-releasing hormone (LHRH) agonist therapy, the evidence of progressive disease should persist after a trial of anti-androgen withdrawal

    • Treatment with LHRH agonist to maintain androgen ablation must continue throughout this trial
  • Baseline PSA ≥ 10 ng/mL

  • All patients with androgen-independent prostate cancer and matched HLA typing are eligible for vaccination regardless of initial NY-ESO-1 expression status

    • Patients must be typed for HLA-DR4, DR13, DP4, or HLA-A2 haplotypes
  • No active brain metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Life expectancy ≥ 12 weeks
  • ANC ≥ 1,500/mm³
  • Hemoglobin ≥ 10 mg/dL
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 mg/dL
  • SGPT ≤ 3 times upper limit of normal
  • Serum creatinine ≤ 2 mg/dL
  • Wiling to be followed at Baylor College of Medicine
  • No serious intercurrent medical illness
  • No history of primary or secondary immunodeficiency
  • No active systemic infection
  • No known hepatitis B surface antigen, hepatitis C, or HIV antibody positivity
  • No history of cardiac arrhythmia or ischemic heart disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 6 weeks since prior immunotherapy (including anti-androgen therapy) and recovered
  • More than 28 days since prior chemotherapy
  • No concurrent immunosuppressive drugs such as systemic corticosteroids

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
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I
MHC Class I binding peptide at 1000 mcg
Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
Experimental: Group II
MHC Class II binding peptide at 1000 mcg
Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
Experimental: Group III
Combination MHC Class I and II binding peptide at 1000 mcg each
Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Tolerability

Secondary Outcome Measures

Outcome Measure
Immunological response

Collaborators and Investigators

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

Sponsor

Baylor College of Medicine

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Teresa G. Hayes, MD, PhD, Veterans Affairs Medical Center - Houston

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

April 1, 2006

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Estimate)

November 6, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000579579
  • P50CA058204 (U.S. NIH Grant/Contract)
  • BCM-H-17274
  • BCM-SPORE-11-01-30-14

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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