Back to resultsVaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage IV prostate cancer
Eligibility Criteria
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
Sites / Locations
- Dan L. Duncan Cancer Center at Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group I
Group II
Group III
Arm Description
MHC Class I binding peptide at 1000 mcg
MHC Class II binding peptide at 1000 mcg
Combination MHC Class I and II binding peptide at 1000 mcg each
Outcomes
Primary Outcome Measures
Tolerability
Toxicity
Secondary Outcome Measures
Immunological response
Full Information
NCT ID
NCT00616291
First Posted
February 14, 2008
Last Updated
November 5, 2012
Sponsor
Baylor College of Medicine
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00616291
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer, stage IV prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
MHC Class I binding peptide at 1000 mcg
Arm Title
Group II
Arm Type
Experimental
Arm Description
MHC Class II binding peptide at 1000 mcg
Arm Title
Group III
Arm Type
Experimental
Arm Description
Combination MHC Class I and II binding peptide at 1000 mcg each
Intervention Type
Biological
Intervention Name(s)
NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
Primary Outcome Measure Information:
Title
Tolerability
Title
Toxicity
Secondary Outcome Measure Information:
Title
Immunological response
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa G. Hayes, MD, PhD
Organizational Affiliation
Veterans Affairs Medical Center - Houston
Official's Role
Study Chair
Facility Information:
Facility Name
Dan L. Duncan Cancer Center at Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23609828
Citation
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.
Results Reference
derived
Learn more about this trial
Vaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer
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