Vaccine Therapy in Treating Patients With Metastatic, Progressive 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: NCT00616291
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : November 6, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Teresa Hayes, Baylor College of Medicine

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine Phase 1

Detailed Description:



  • 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.


  • 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  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14)
Study Start Date : April 2006
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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

Primary Outcome Measures :
  1. Tolerability
  2. Toxicity

Secondary Outcome Measures :
  1. Immunological response

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


  • 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


  • 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


  • 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

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): NCT00616291

United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Cancer Institute (NCI)
Study Chair: Teresa G. Hayes, MD, PhD Veterans Affairs Medical Center - Houston

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Teresa Hayes, Associate Professor, Baylor College of Medicine Identifier: NCT00616291     History of Changes
Obsolete Identifiers: NCT00711334
Other Study ID Numbers: CDR0000579579
P50CA058204 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: November 6, 2012
Last Verified: November 2012

Keywords provided by Teresa Hayes, Baylor College of Medicine:
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Immunologic Factors
Physiological Effects of Drugs