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