INCLUSION CRITERIA
The inclusion criteria for registration into the protocol are:
-Subjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements:
Stage IIIA (T3N2 only) or
Stage IIIB or
Stage IV.
-Subjects must have stable disease (SD) or an objective response (PR or CR) to a prior single, frontline, platinum-based chemotherapy regimen (additional prior adjuvant chemotherapy is permitted) consisting of up to six (6) treatment cycles with or without concomitant radiation therapy.
-Not less than one month nor more than four months must have elapsed since the completion of the last chemotherapy cycle and registration into the study.
-Signed informed consent.
-Not less than 18 years and not more than 75 years old.
-Estimated life expectancy of at least 12 weeks.
-Performance status (ECOG) less than or equal to 2.
-Absolute neutrophil count greater than or equal to 1,500/mm(3).
-Hemoglobin greater than or equal to 9 g/dL.
-Platelet count greater than or equal to 100,000/mm(3).
-Albumin levels greater than or equal to 3.5 g/dL.
-Bilirubin less than or equal to 1.5 times the upper limit of normal (ULN).
-Aspartate transaminase (AST) and Alanine transaminase (ALT) less than or equal to 1.5 x ULN.
-Creatinine less than or equal to 1.5 x ULN.
-Alkaline phosphatase less than or equal to 5 x ULN.
EXCLUSION CRITERIA
-Concurrent systemic steroids greater than 2 mg/day prednisone (or prednisone-equivalent of prednisolone or dexamethasone).
-Prior splenectomy.
-Any surgery involving general anesthesia less than 4 weeks prior to study registration.
-Chemotherapy more than 4 months or less than 4 weeks prior to study registration.
-Steroid therapy (excluding less than or equal to 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, or immunotherapy less than 4 weeks prior to study registration.
-Objective evidence of brain metastases.
-Painful bone metastases, or bone metastases that require immediate therapy.
-Significant and/or symptomatic pleural effusions. Presence of clinically detectable (by physical exam) third-space fluid collections, for example, pleural effusions that cannot be controlled by previous chemotherapy and/or drainage, or other procedures, prior to study entry.
-Known allergies to eggs or soy.
-Significant weight loss (greater than or equal to 10% body weight in preceding 6 weeks).
-Known HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV).
-Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections) or other conditions that, in the opinion of the investigator, would compromise study objectives.
-NCI CTC Grade 3 or 4 peripheral neuropathy at study registration.
-Prior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for greater than or equal to 2 years.
-History of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements.
-Pregnant or nursing women, or refusal to practice contraception if of reproductive potential.
-Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
-Known active Epstein-Barr infection within less than or equal to 60.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/15/2008