NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
Condition: Prostate Cancer; Bladder Cancer; Non-small Cell Lung Cancer; Esophageal Cancer; Sarcoma
Intervention: NY-ESO-1 Plasmid DNA Cancer Vaccine
Intervention description: NY-ESO-1 Plasmid DNA Cancer Vaccine administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NY-ESO-1; DNA

Summary:

      To evaluate the safety of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine given by
      particle-mediated epidermal delivery (PMED) in patients with tumor types known to express
      NY-ESO-1 or LAGE-1.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients were eligible for enrollment if they fulfilled all of the following criteria:

          1. 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.

          2. Advanced disease and have declined, delayed, failed or completed standard therapy.

          3. Full recovery from surgery.

          4. Expected survival of at least 6 months.

          5. Karnofsky performance scale ≥ 60.

          6. Adequate bone marrow, kidney, liver and immune functions.

          7. Able and willing to give valid written informed consent.

        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.