Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: NY-ESO-1 protein/CpG 7909
Intervention description: Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle).
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NY-ESO-1 protein, immunization, advanced prostate cancer

Summary:

      This was a Phase 1, open-label, fixed-dose study of immunization with the NY-ESO-1 protein
      combined with CpG 7909 as an adjuvant in patients with histopathologically confirmed,
      high-risk Stage D1 or advanced prostate cancer. The primary study objective was to assess the
      safety of NY-ESO-1 protein/CpG 7909 immunization, and the secondary objective was to evaluate
      the immunity induced by immunization.
    

Eligibility criteria:

        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.