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

Inclusion Criteria

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

• Histologically proven tumor type known to express NY-ESO-1 or LAGE-1 (prostate cancer, breast cancer, bladder cancer, hepatocellular cancer, synovial sarcoma, leiomyosarcoma, head and neck, lung cancer, esophageal, ovarian, neuroblastoma); or NY-ESO-1 or LAGE-1 positive tumors determined by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis, preferably, or immunohistochemistry or expression of LAGE-1 by RT-PCR.
• Advanced disease and have declined, delayed, failed or completed standard therapy.
• Full recovery from surgery.
• Expected survival of at least 6 months.
• Karnofsky performance scale ≥ 60.
• Adequate bone marrow, kidney, liver and immune functions.
• Able and willing to give valid written informed consent.

Exclusion Criteria

• Clinically significant heart disease (NYHA Class III or IV).
• Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders, clinically significant liver or renal insufficiency requiring treatment.
• Patients with serious intercurrent illness, requiring hospitalization.
• Known HIV, Hepatitis B or Hepatitis C positivity.
• History of autoimmune diseases (e.g. SLE, scleroderma). Vitiligo is not an exclusion criterion.
• 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.
• Evidence of skin disease (e.g. psoriasis, eczema or keloid formation) at the proposed administration site.
• Allergy to gold (including gold jewelry).
• History or evidence of chrysotherapy (gold salts).
• Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing (6 weeks for nitrosoureas).
• Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer, cervical carcinoma in situ.
• 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.
• Lack of availability for immunological and clinical follow-up assessments.
• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
• Pregnancy or breastfeeding.
• Women of childbearing potential: Refusal or inability to use effective means of contraception.