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

Phase 1
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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



- 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


- 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

- 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

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

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

Inclusion Criteria


- 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

- More than 28 days since prior chemotherapy

- No concurrent immunosuppressive drugs such as systemic corticosteroids

Type of Study:


Study Design:

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Safety Issue:


Principal Investigator

Teresa G. Hayes, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Veterans Affairs Medical Center - Houston


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

July 2011

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



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