Status:
COMPLETED
Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well vaccine therapy works in treating patients with recurrent prostate cancer. Vaccines made from peptides may help the body build an effective immune response to ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the T-lymphocyte immune response in patients with recurrent adenocarcinoma of the prostate treated with prostate-specific antigen (PSA) peptide vaccine (PSA-3A; PSA: ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- Must have undergone radical prostatectomy ≥ 3 months ago
- Prostate-specific antigen (PSA) level ≥ 0.6 ng/mL and rising (after radical prostatectomy) on ≥ 2 measurements separated by ≥ 3 months
- HLA-A2-positive peripheral blood mononuclear cells by flow cytometry
- No clinical evidence of local recurrence
- No palpable induration or mass in prostatic fossa
- No metastatic prostate cancer
- No osseous metastases by bone scan
- Performance status - ECOG 0-1
- Performance status - Karnofsky 70-100%
- More than 1 year
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- AST and ALT ≤ 2.5 times upper limit of normal
- Bilirubin normal
- Hepatitis B and C negative
- Creatinine normal
- Creatinine clearance ≥ 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study PSA peptide vaccine or Montanide ISA-51
- No history of systemic autoimmune disease or autoimmune disease requiring anti-inflammatory or immunosuppressive therapy
- Patients with history of autoimmune thyroiditis are eligible provided the patient requires only thyroid hormone replacement therapy AND disease has been stable for ≥ 1 year
- No known HIV positivity
- No ongoing or active infection
- No primary or secondary immune deficiency
- No psychiatric illness or social situation that would preclude study compliance
- No history of other uncontrolled illness
- No prior chemotherapy
- No prior hormonal therapy
- No concurrent systemic or ocular steroid therapy, except for any of the following:
- Inhaled steroids for asthma
- Limited topical steroids
- Replacement doses of cortisone
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to the prostate
- Prior radiotherapy to the pelvis after radical prostatectomy allowed
- See Disease Characteristics
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00109811
Start Date
March 1 2005
Last Update
January 23 2013
Active Locations (1)
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1
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1595