Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer
Completed · Phase 2
Conditions studied: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer
In brief
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 kill tumor cells
Key facts
- Study ID
- NCT00109811
- Run by
- National Cancer Institute (NCI)
- People needed
- 32
- Starts
- 2005-03-01
- Last updated by the study team
- 2013-01-23
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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