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