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

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.