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:

1. High-risk Stage D1 or metastatic prostate cancer (D2), confirmed by review of histology.
2. Fully recovered from surgery.
3. 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.
4. 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.
5. Expected survival of ≥ 3 months.
6. Karnofsky performance status of ≥ 70%.
7. 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.
8. Age ≥ 18 years.
9. Able to give valid written informed consent.

Exclusion Criteria

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

1. 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).
2. Other serious illnesses, e.g., active infections requiring antibiotics, bleeding disorders.
3. Concomitant systemic treatment with corticosteroids. Topical or inhalational steroids were permitted.
4. Metastatic disease to the central nervous system.
5. 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.
6. Lack of availability for immunological and clinical follow-up assessments.
7. Participation in chemotherapy, radiation therapy, or any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
8. 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.