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| Descriptive Information Fields | |||||
| Brief Title † | Vaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer | ||||
| Official Title † | Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14) | ||||
| Brief 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Tolerability [ Designated as safety issue: Yes ] Toxicity [ Designated as safety issue: Yes ] |
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| Secondary Outcome Measure † | Immunological response [ Designated as safety issue: No ] | ||||
| Condition † | Prostate Cancer | ||||
| Intervention † | Drug: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 18 | ||||
| Start Date † | April 2006 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00616291 | ||||
| Organization ID | CDR0000579579 | ||||
| Secondary IDs †† | BCM-H-17274, BCM-SPORE-11-01-30-14 | ||||
| Study Sponsor † | Baylor College of Medicine | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | February 14, 2008 | ||||
| Last Updated Date | July 23, 2008 | ||||