Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With Prostate Cancer

Inclusion Criteria

Patients were eligible for enrollment if they fulfilled the following criteria:

• High-risk Stage D1 or metastatic prostate cancer (D2), confirmed by review of histology.
• Fully recovered from surgery.
• Showed stable or progressive disease as assessed by X-ray, ultrasound, and/or computed tomography (CT) scans under hormonal and/or chemotherapeutic treatment, which had been administered for ≥ 3 months.
• Any pretreatment with chemo- or radiotherapy must have been discontinued for ≥ 4 weeks prior to the first dose of study agent. Hormone therapy was allowed before and throughout the study.
• Expected survival of ≥ 3 months.
• Karnofsky performance status of ≥ 70%.
• Within the last 2 weeks prior to study day 1, vital laboratory parameters should have been within the normal range, except for the following laboratory parameters, which should have been within the ranges specified:
• Leukocytes > 3,000/µl.
• Lymphocytes > 700/µl.
• Platelets > 100,000/µl.
• Serum creatinine < 2.5 mg/dL.
• Alanine aminotransferase, aspartate aminotransferase, and total bilirubin < 2.5 x upper limit of normal.
• Age ≥ 18 years.
• Able to give valid written informed consent.

Exclusion Criteria

Patients were excluded from the study if they fulfilled any of the following criteria:

• Clinically significant heart disease (i.e., New York Heart Association Class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
• Other serious illnesses, e.g., active infections requiring antibiotics, bleeding disorders.
• Concomitant systemic treatment with corticosteroids. Topical or inhalational steroids were permitted.
• Metastatic disease to the central nervous system.
• Mental impairment, in the opinion of the Investigator, that may have compromised the ability to give informed consent and comply with the requirements of the study.
• Lack of availability for immunological and clinical follow-up assessments.
• Participation in chemotherapy, radiation therapy, or any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
• Being a recipient of an organ or bone marrow allograft. Having an autoimmune disease other than vitiligo, such as, but not limited to, inflammatory bowel disease or multiple sclerosis.