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| Sponsors and Collaborators: |
Baylor College of Medicine National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00616291 |
Purpose
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.
| Condition | Intervention | Phase |
|
Prostate Cancer |
Drug: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine |
Phase I |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14) |
| Estimated Enrollment: | 18 |
| Study Start Date: | April 2006 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer with evidence of progressive disease despite hormonal therapy (i.e., hormone-refractory prostate cancer)
Progressive disease defined by any of the following:
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
All patients with androgen-independent prostate cancer and matched HLA typing are eligible for vaccination regardless of initial NY-ESO-1 expression status
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Texas | |||||
| Dan L. Duncan Cancer Center at Baylor College of Medicine | Recruiting | ||||
| Houston, Texas, United States, 77030 | |||||
| Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor 713-798-1297 | |||||
| Baylor College of Medicine |
| National Cancer Institute (NCI) |
| Study Chair: | Teresa G. Hayes, MD, PhD | Veterans Affairs Medical Center - Houston |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000579579, BCM-H-17274, BCM-SPORE-11-01-30-14 |
| First Received: | February 14, 2008 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00616291 |
| Health Authority: | Unspecified |
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