Vaccination of Advanced-Stage Lung Cancer Patients

Inclusion Criteria:

1. Advanced-stage (i.e., metastatic) Lung Cancer of any histologic type

2. (Computed Tomography) CT scans were completed within 4 weeks prior to registration

3. Age 18 years and older

4. ECOG Performance Status 0 to 2

5. White blood cell (WBC) count ≥ 3,000/mm3 within 3 weeks prior to registration

6. Platelet count ≥ 100,000/mm3 within 3 weeks prior to registration

7. Serum glutamic-pyruvic transaminase (SGPT) or alanine aminotransferase test (ALT) ≤ 2
x institutional upper limit (IUL) of normal obtained within 3 weeks prior to
registration

8. Serum glutamic-oxaloacetic transaminase (SGOT) or aspartate aminotransferase test
(AST) ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to
registration

9. Serum creatinine ≤ 1.8 mg/dL obtained within 3 weeks prior to registration

10. Radiation is allowed

Exclusion Criteria:

1. Active infection requiring treatment with antibiotics

2. Any other significant medical or psychiatric conditions which, in the opinion of the
enrolling investigator, may interfere with consent or compliance of the treatment
regimen

3. Existing diagnosis or evidence of organic brain syndrome that might preclude
participation in the full protocol

4. Existing diagnosis or history of significant impairment of basal cognitive function
that might preclude participation in the full protocol

5. Existing diagnosis or history of leptomeningeal disease, spinal cord compression or
brain metastases unless: (a) metastases have been locally treated and have remained
clinically controlled and asymptomatic for at least 14 days following treatment, AND
(b) subject has no residual neurological dysfunction and has been off corticosteroids
for at least 14 days prior to registration

6. Other current malignancy(s): Subjects with prior history at any time of any in situ
cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ,
atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin
cancer are eligible, provided they are disease-free at the time of registration.
Subject has other malignancies have been continuously disease free for ≥ 5 years prior
to the time of registration. Subjects with other malignancies are eligible if they
have been continuously disease free for ≥ 5 years prior to the time of registration.

7. Active autoimmune disorders or conditions of immunosuppression; Existing autoimmune
disorders or conditions of immunosuppression that have been in remission for less than
6 months.

8. Treatment with corticosteroids, including oral steroids (i.e. prednisone,
dexamethasone), continuous use of topical steroid creams or ointments or any
steroid-containing inhalers. Subjects who have been on systemic steroids will require
a 6-week washout period. Subjects who discontinue the use of these classes of
medication for at least 6 weeks prior to registration are eligible if, in the judgment
of the treating physician, the subject is not likely to require these classes of drugs
during the treatment period. Replacement doses of steroids for subjects with adrenal
insufficiency are allowed.