| ID | Type | Description | Link |
|---|---|---|---|
| P50CA058204 | U.S. NIH Grant/Contract | View source | |
| BCM-H-17274 | |||
| BCM-SPORE-11-01-30-14 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
Primary
Secondary
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | MHC Class I binding peptide at 1000 mcg |
|
| Group II | Experimental | MHC Class II binding peptide at 1000 mcg |
|
| Group III | Experimental | Combination MHC Class I and II binding peptide at 1000 mcg each |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability | ||
| Toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological response |
Not provided
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:
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
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
No active brain metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Teresa G. Hayes, MD, PhD | Veterans Affairs Medical Center - Houston | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dan L. Duncan Cancer Center at Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23609828 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |