DNP-Modified Autologous Tumor Cell Vaccine for Resectable Non-Small Cell Lung Cancer

Inclusion Criteria:

• Histologically documented stage IA, IB, IIA, IIB or IIIA NSCLC that is completely resectable and does not require post-operative radiation therapy or peri-operative chemotherapy
• Excision of the tumor and harvesting of tumor mass yielding adequate cells for vaccine manufacture and DTH testing
• Successful preparation and lot release of vaccines and of DTH testing material containing DNP-modified tumor cells
• Minimum of 3 and maximum of 8 weeks since the surgery
• Expected survival of at least 6 months
• Karnofsky performance status ³ 80
• Signed informed consent

Exclusion Criteria:

Alkaline phosphatase > 2.5 x ULN

• Total bilirubin > 2.0 mg/dL
• Creatinine > 2.0 mg/dL
• Hemoglobin < 10.0 g/dL
• WBC < 3,000 /mm3
• Platelet count < 100,000/mm3
• Chemotherapy - pre-operative or post-operative (except as designated in protocol)
• Radiation therapy to lung - pre-operative or post-operative
• Any major field radiotherapy within 6 months prior to participation in the study
• Immunotherapy (interferons, tumor necrosis factor, other cytokines [e.g., interleukins], biological response modifiers, or monoclonal antibodies) within 4 weeks prior to participation in the study
• Prior splenectomy
• Concurrent use of systemic steroids, except for the period of administration of the adjuvant chemotherapy, as per Section 8.6 (months 4-7)(Note: Topical steroid therapies [applied to the skin] are allowed, provided these are not applied to limbs injected with vaccine or skin test materials. Inhaled aerosol steroids are allowed.)
• Concurrent use of immunosuppressive drugs, except for the period of administration of the adjuvant chemotherapy (months 4-7)
• Concurrent use of antitubercular drugs (isoniazid, rifampin, streptomycin)
• Other malignancy within 5 years except curatively treated non-melanomatous skin cancer and curatively treated carcinoma in situ of the uterine cervix, or early stage (stage A or B1) prostate cancer
• Concurrent autoimmune diseases, e.g., systemic lupus erythematosus, multiple sclerosis or ankylosing spondylitis
• Concurrent medical condition that would preclude compliance or immunologic response to study treatment
• Concurrent serious infection or other serious medical condition
• Receipt of any investigational medication within 4 weeks prior to participation in the study
• Pregnancy or lactation (serum b-human chorionic gonadotropin [b-HCG] test must be negative in fertile women at screening visit)
• Active tuberculosis or a past history of tuberculosis
• PPD positive (³ 5 mm to 5TU)
• Known gentamicin sensitivity
• Anergic, defined by the inability to make a DTH to at least one of the following: candida, mumps, tetanus or trichophyton (based, except for the period of administration of the adjuvant chemotherapy (months 4-7) upon availability)
• Vaccine lot release failure