Vaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  |  | 
| Toxicity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological response |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer, stage IV prostate cancer