Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer

The study is an open label investigation of the cellular vaccine called 1650-G. Patients
receive 2 vaccine injections intradermally in the thigh given 4 weeks apart. Patients will be
followed weekly after each vaccine injection and then monthly for 4 months. Patient follow-up
continues with evaluations at 6 months and 1 year after receiving the first vaccine
injection. Immunologic responses to the vaccine will be assessed from blood samples obtained
at each visit following immunizations.

Inclusion Criteria:

- Histologically confirmed Stage I or Stage II Non-Small Cell Lung Cancer

- Surgically resected at least 4 weeks ago but not more than 6 months ago

- Bronchoalveolar carcinomas allowed

- Completion of any chemotherapy or radiation given in conjunction with Surgery
(neoadjuvant or adjuvant)

- No evidence of disease following initial therapy evidenced by a CXR, CT or PET scan
within 6 weeks of enrollment

- ECOG performance status of 0 to 2

- Adequate organ and marrow function defined as follows:

- Hemoglobin ≥9.0 gm/dL

- Bilirubin < 2.5 x upper limit of normal

- AST <2.5 x upper limit of normal

- ALT <2.5 x upper limit of normal

- Creatinine <3 mg/dL

- Women of childbearing potential must have a negative pregnancy test and be willing to
use acceptable methods of contraception through week 16.

Exclusion Criteria:

- Cardiovascular disease defined as:

- New York Heart Association Class III or IV (Section 19.2) congestive heart
failure

- hemodynamically significant valvular heart disease

- myocardial infarction within the last six months

- active angina pectoris

- uncontrolled ventricular arrhythmias

- stroke within one year

- known cerebrovascular disease

- History of HIV, infectious hepatitis, or chronic immunosuppressive disease

- concurrent shorter courses of immunosuppressive medications during and for 16 weeks
after study treatment

- History of an allergic reactions to any colony stimulating factor (GCSF, GMCSF)

- Female patients must not be pregnant or breastfeeding.

- History of participation in any investigational drug study within 4 weeks preceding
initiation of study treatment.