Epigenetically-Modified Autologous Tumor Cell Vaccines With ISCOMATRIX(TM) Adjuvant and Oral Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thoracic Sarcomas, and Malignant Pleural Mesotheliomas

Inclusion Criteria

- ELIGIBILITY CRITERIA:

INCLUSION CRITERIA PRIOR TO SURGERY (SCREENING CONSENT):

1. Patients with resectable primary small cell or non-small cell lung cancers,
esophageal cancers, primary sarcoma of the chest, or pleural mesotheliomas are
eligible for treatment.

2. Patients with intracranial metastases, which have been treated by surgery or
radiation therapy may be eligible for study provided there is no evidence of active
disease.

3. Patients with prior Decitabine exposure are eligible for study.

4. Patients must have an ECOG performance status of 0 - 2.

5. Patients must be 18 years of age or older due to the unknown effects of immunologic
responses to germ cell-restricted gene products during childhood and adolescent
development.

6. Seronegative for HIV antibody. Note: The experimental treatment being evaluated in
this protocol depends on an intact immune system. Patients who are HIV seropositive
can have decreased immune competence and thus may be less responsive to the
experimental treatment.

7. Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. If
hepatitis C antibody test is positive, then patient must be tested for the presence
of antigen by RT-PCR and be HCV RNA negative.

8. Patients must be aware of the neoplastic nature of their illnesses, the experimental
nature of the therapy, alternative treatments, potential benefits, and risks.

9. Patients must be willing to sign an informed consent, and undergo resection of their
malignancies at the NCI, to ensure vaccine development.

INCLUSION CRITERIA FOR TREATMENT PHASE OF PROTOCOL (STANDARD CONSENT):

1. Patients must have signed the Screening Consent

2. Patients who were initially rendered NED by surgical resection must remain NED at the
time of treatment.

3. Patients with no more than 3 intracranial metastases, which have been definitively
treated by surgery or radiation therapy may be eligible for the study, provided there
is no evidence of active disease for at least 2 months and no requirement for
anticonvulsant therapy or steroids following treatment.

4. Patients must have an ECOG performance status of 0 - 2.

5. Patients must have evidence of adequate bone marrow reserve, hepatic and renal
function as evidenced by the following laboratory parameters:

- Absolute neutrophil count greater than 1500/mm(3)

- Platelet count greater than 100,000/mm(3)

- Hemoglobin greater than 8g/dl ( patients may receive transfusions to meet this
parameter

- PT within 2 seconds of the ULN

- Total bilirubin < 1.5 times upper limits of normal

- Serum creatin ine less than or equal to 1.6 mg/ml or the creatinine clearance
must be greater than 70 ml/min/1.73M(2).

6. Seronegative for HIV antibody. Note: The experimental treatment being evaluated in
this protocol depends on an intact immune system. Patients who are HIV seropositive
can have decreased immune competence and thus may be less responsive to the
experimental treatment.

7. Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. If
hepatitis C antibody test is positive, then patient must be tested for the presence
of antigen by RT-PCR and be HCV RNA negative.

8. Patients must be willing to practice birth control during and for four months
following treatment.

9. Patients must be willing to sign the standard informed consent.

EXCLUSION CRITERIA FOR TREATMENT PHASE OF PROTOCOL:

1. Patients unable/unwilling to undergo resection of their malignancies at the NCI will
be excluded.

2. Patients who are initially rendered NED by combined modality therapy but exhibit
disease progression prior to initiation of vaccination will be excluded from the
treatment portion of the study.

3. Patients who will have received more than two systemic cytotoxic treatment regimens
for their thoracic malignancy by the time vaccination commences will be excluded.

4. Patients requiring corticosteroids (other than inhaled) will be excluded.

5. Patients with life expectancy less than 12 months will be excluded.

6. Patients receiving warfarin anticoagulation, who cannot be transferred to other
agents such as enoxaparin or dabigatran, and for whom anticoagulants cannot be held
for up to 24 hours will be excluded.

7. Patients with uncontrolled hypertension (> 160/95), unstable coronary disease
evidenced by uncontrolled arrhythmias, unstable angina, decompensated CHF (> NYHA
Class II), or myocardial infarction within 6 months of study will be excluded.

8. Patients with other cardiac diseases may be excluded at the discretion of the PI
following consultation with Cardiology consultants.

9. Patients with any of the following pulmonary function abnormalities will be excluded:
FEV, < 30% predicted; DLCO < 30% predicted (post-bronchodilator); pO2 < 60% or
pCO2 greater than or equal to 50 on room air arterial blood gas.

10. Pregnant and/or lactating women will be excluded due to the unknown, potentially
harmful effects of immune response to CT-X antigens and stem cell proteins that may
be expressed in placenta, fetus, and neonates.

11. Patients with active infections, including HIV, will be excluded, due to unknown
effects of the vaccine on lymphoid precursors.

12. Patients with any type of primary immunodeficiencies will be excluded from the study.