NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine

Exclusion Criteria

• •1. Clinically significant heart disease (NYHA Class III or IV).
• •2. Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders, clinically significant liver or renal insufficiency requiring treatment.
• •3. Patients with serious intercurrent illness, requiring hospitalization.
• •4. Known HIV, Hepatitis B or Hepatitis C positivity.
• •5. History of autoimmune diseases (e.g. SLE, scleroderma). Vitiligo is not an exclusion criterion.
• •6. Concomitant systemic treatment with corticosteroids, anti-histaminic drugs or non-steroidal anti-inflammatory drugs. Specific COX-2 inhibitors are permitted. Low dose aspirin is permitted. Topical or inhalational steroids are permitted.
• •7. Evidence of skin disease (e.g. psoriasis, eczema or keloid formation) at the proposed administration site.
• •8. Allergy to gold (including gold jewelry).
• •9. History or evidence of chrysotherapy (gold salts).
• •10. Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing (6 weeks for nitrosoureas).
• •11. Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer, cervical carcinoma in situ.
• •12. Mental impairment, in the opinion of the investigator, that may compromise the ability to give informed consent and comply with the requirements of the study.
• •13. Lack of availability for immunological and clinical follow-up assessments.
• •14. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
• •15. Pregnancy or breastfeeding.
• •16. Women of childbearing potential: Refusal or inability to use effective means of contraception.