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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.
ClinicalTrials.gov Identifier: NCT00616291
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : November 6, 2012
Information provided by (Responsible Party):

February 14, 2008
February 15, 2008
November 6, 2012
April 2006
July 2011   (Final data collection date for primary outcome measure)
  • Tolerability
  • Toxicity
Same as current
Complete list of historical versions of study NCT00616291 on ClinicalTrials.gov Archive Site
Immunological response
Same as current
Not Provided
Not Provided
Vaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer
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.



  • 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.

Phase 1
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
  • Experimental: Group I
    MHC Class I binding peptide at 1000 mcg
    Intervention: Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
  • Experimental: Group II
    MHC Class II binding peptide at 1000 mcg
    Intervention: 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
    Intervention: Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
Sonpavde G, Wang M, Peterson LE, Wang HY, Joe T, Mims MP, Kadmon D, Ittmann MM, Wheeler TM, Gee AP, Wang RF, Hayes TG. HLA-restricted NY-ESO-1 peptide immunotherapy for metastatic castration resistant prostate cancer. Invest New Drugs. 2014 Apr;32(2):235-242. doi: 10.1007/s10637-013-9960-9. Epub 2013 Apr 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2011
July 2011   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
P50CA058204 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Teresa Hayes, Baylor College of Medicine
Baylor College of Medicine
National Cancer Institute (NCI)
Study Chair: Teresa G. Hayes, MD, PhD Veterans Affairs Medical Center - Houston
Baylor College of Medicine
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP