L-Vax: A Feasibility Study Using a DNP-Modified Autologous Tumor Cell Vaccine as Therapy in Patients With 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