Status:
COMPLETED
Vaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 treat...
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00616291
Start Date
April 1 2006
End Date
July 1 2011
Last Update
November 6 2012
Active Locations (1)
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1
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030