A Phase II Randomized Study of GM-CSF Gene-Modified Autologous Tumor Vaccine (CG8123) With and Without Low-Dose Cyclophosphamide in Advanced Stage Non-Small Cell Lung Cancer
Inclusion Criteria:
- 18 years or older
- Suspicious diagnosis of or histologically- confirmed stage IIIB or IV non small-cell
lung cancer
- Accessible and adequate tumor source for vaccine production.
- Tumor source for vaccine production must be accessible by a minor surgical procedure
performed under local or regional anesthesia (e.g. lymph node or soft tissue mass or
malignant pleural effusion)
- Measurable disease to evaluate following tumor procurement
- Limited metastatic tumor burden
- Life expectancy at least 4 months
- ECOG Performance Status 0 - 1
Exclusion Criteria:
- Active and/or untreated brain metastases
- Active or impending spinal cord compression
- Active auto-immune disease or treatment with immunosuppressants
- Decompensated congestive heart failure or recent significant cardiac event
- Coexisting malignancies
- Significant or uncontrolled medical problems or laboratory abnormalities that might
increase the risk of surgical complications or vaccine treatment
- Previous treatment with gene therapy (including any adenoviral-based therapy)