CompletedNCT00616291Updated Nov 6, 2012

Vaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer

A Phase 1 interventional study of NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine in Prostate Cancer, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-06.

Sponsored by Baylor College of Medicine · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 14
Ages: 18 Years and older
Sex: Male

Study 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.

Read the 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.

Conditions studied

Prostate Cancer

Browse trials for

Prostatic Neoplasms 6,370

Keywords

recurrent prostate cancer
stage IV prostate cancer

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 14 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

Eligibility criteria

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 design

Phase: Phase 1
Primary purpose: Treatment
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 14 participants (actual)

Study arms

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

Interventions

BiologicalNY-ESO-1/LAGE-1 HLA class I/II peptide vaccine

What researchers measure

Primary outcomes

Tolerability
Toxicity

Secondary outcomes

Immunological response

Study locations

1 site

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

References and documents

Publications

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. PubMed 23609828 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00616291
Lead sponsor: Baylor College of Medicine
Collaborators: National Cancer Institute (NCI)
Responsible party: Teresa Hayes (Associate Professor, Baylor College of Medicine) — Principal investigator
First posted: Feb 15, 2008
Start date: Apr 2006
Primary completion: Jul 2011
Completion: Jul 2011
Last update: Nov 6, 2012

Study contacts

Teresa G. Hayes, MD, PhD

study chair · Veterans Affairs Medical Center - Houston

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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