NY-ESO-1 Protein With Montanide and CpG 7909 as Cancer Vaccine in Several Tumors

Inclusion Criteria:

1. Histological diagnosis of hepatocellular carcinoma, bladder cancer, breast cancer, non-small lung cancer (NSCLC), melanoma, sarcoma, prostate cancer, esophageal cancer, or ovarian cancer, independent of NY-ESO-1 expression in a tumor biopsy.

   or

   Histological diagnosis of other types of cancers, provided NY-ESO-1 or LAGE-1 expression can be shown in a tumor biopsy.
2. At least 4 weeks since surgery prior to first dosing of study agent.
3. Laboratory values within the following limits:

   * Hemoglobin ≥ 11.0 g/dL
   * Neutrophil count ≥ 1.5 x l0\^9/L
   * Lymphocyte count ≥ lower limit of institutional normal
   * Platelet count ≥ 80 x l0\^9/L
   * Serum creatinine ≤ 2.0 mg/dL
   * Serum bilirubin ≤ 2 x upper limit of institutional normal
   * AST/ALT ≤ 2 x upper limit of institutional normal
4. Patients must have a Karnofsky performance status of ≥70%.
5. Life expectancy ≥ 6 months.
6. Age ≥ 18 years.
7. Able and willing to give witnessed, written informed consent for participation in the trial.

Exclusion Criteria:

1. Clinically significant heart disease (i.e. NYHA class 3 congestive heart failure; myocardial infarction within the past six months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
2. Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
3. Previous bone marrow or stem cell transplant.
4. History of immunodeficiency disease or autoimmune disease except vitiligo.
5. Metastatic disease to the central nervous system, unless treated and stable.
6. Other malignancy within 3 years prior to entry into the study, except for treated early-stage melanoma or non-melanoma skin cancer, or cervical carcinoma in situ.
7. Known HIV, Hepatitis B or Hepatitis C positivity.
8. Chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to first dose of study agent (6 weeks for nitrosoureas).
9. Concomitant treatment with steroids. Topical or inhalational steroids are permitted.
10. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent.
11. Pregnancy or lactation.
12. Women of childbearing potential not using a medically acceptable means of contraception.
13. Psychiatric or addictive disorders that may compromise the ability to give informed consent.
14. Lack of availability of the patient for immunological and clinical follow-up assessment.