Vaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer
NCT ID: NCT00616291
Last Updated: 2012-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2006-04-30
2011-07-31
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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Group I
MHC Class I binding peptide at 1000 mcg
NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
Group II
MHC Class II binding peptide at 1000 mcg
NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
Group III
Combination MHC Class I and II binding peptide at 1000 mcg each
NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
Interventions
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NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Baylor College of Medicine
OTHER
Responsible Party
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Teresa Hayes
Associate Professor
Principal Investigators
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Teresa G. Hayes, MD, PhD
Role: STUDY_CHAIR
Veterans Affairs Medical Center - Houston
Locations
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Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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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.
Other Identifiers
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BCM-H-17274
Identifier Type: -
Identifier Source: secondary_id
BCM-SPORE-11-01-30-14
Identifier Type: -
Identifier Source: secondary_id
CDR0000579579
Identifier Type: -
Identifier Source: org_study_id
NCT00711334
Identifier Type: -
Identifier Source: nct_alias