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