Phase I Trial of TGFB2-Antisense-GMCSF Gene Modified Autologous Tumor Cell (TAG) Vaccine for Advanced Cancer

Inclusion Criteria:

- Histologically confirmed advanced or metastatic non-curable solid tumor (if limited
to a single lesion and not a candidate for curative surgery or radiation therapy).

- Completed ≥1 conventional therapy.

- Clinically indicated surgery or procedure to collect available tumor in sufficient
quantity ("golf ball size," pleural or ascites fluid may also be collected) for
vaccine processing.

- Subjects that have completed all acceptable therapies that are the current standard
of care for their respective diseases.

- Recovered from all toxicities related to prior therapies.

- Subjects with brain metastases treated at least ≥2 months prior to enrollment,
without related clinical symptoms and must have a stable neurological exam on the
screening evaluation.

- ≥1 measurable or evaluable lesion.

- Age ≥18 years.

- ECOG performance status (PS) 0-1.

- Normal organ and marrow function:

- Absolute granulocyte count: ≥1,500/mm3

- Platelets: ≥100,000/mm3

- Total bilirubin: ≤2 mg/dL

- AST(SGOT)/ALT(SGPT): ≤2x institutional upper limit of normal

- Creatinine: <1.5 mg/dL

- Ability to understand and the willingness to sign a written informed consent
document.

- Negative pregnancy test.

Exclusion Criteria:

- Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or
immunotherapy within 4 weeks prior to entering the study.

- Patient must not have received any other investigational agents within 30 days prior
to study entry.

- Patients with known brain metastases unless treated and stable for ≥2 months.

- Patients with mucinous adenocarcinoma.

- Short term (<30 days) concurrent systemic steroids ≤ 0.125 mg/kg prednisone per day
(maximum 10 mg/day) and bronchodilators (inhaled steroids) are permitted; other
steroid regimens and/or immunosuppressives are excluded. Patients requiring steroids
following previous CNS radiation for metastatic disease are excluded.

- Prior splenectomy.

- Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission
for ≥2 years.

- Kaposi's Sarcoma.

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Patients who are pregnant or nursing.

- Patients who are HIV positive.

- Patients with chronic Hepatitis B and C infection.

- Patients with a history of autoimmune diseases.