Inclusion Criteria:
Screening, physical exams, blood draws, CT scans, and follow-up will be performed at VA
Greater Los Angeles. All interventional procedures including leukapheresis, CT
guided/bronchoscopic biopsies and vaccine injections will be performed at University of
California Los Angeles (UCLA).
- Adults over the age of 21 capable of giving informed consent
- Pathologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIB, IV or recurrent disease
- Progressive disease despite one or more prior chemotherapy regimens as standard of
care OR patient refusal of standard chemotherapy
- Measurable metastatic disease by RECIST guidelines
- Patients with a major endobronchial lesion in the segmental, lobar, or mainstem
bronchus with complete obstruction of the airway may be eligible for bronchoscopic
injection provided there is no evidence of respiratory failure (defined as SaO2 at
least 90% on room air, PCO2 less than, or equal to 45 mm Hg, or FEV1 greater than
1.0L)
- Patients with an endobronchial lesion in the segmental bronchus with variable
stenosis (not completely obstructed) and not amenable to standard palliative airway
treatments (i.e., laser and stenting) may be eligible for bronchoscopic injection if
there is no indication of respiratory failure as defined above
- Patient with bullous disease may undergo CT-guided transthoracic injection provided
the targeted tumor has an intended needle path without crossing bullae
- ECOG performance status 0-2
- BUN less than or equal to 40 OR serum creatinine less than 2 Serum total bilirubin
less than or equal to 1.5 OR serum transaminases less than or equal to 2.5 times
upper limit of normal (ULN)
- Negative pregnancy test (if applicable)
- Fertile patients must use effective contraception
- More than 14 days since prior acute therapy for viral, bacterial, or fungal
infections
- More than 30 days since prior and no concurrent corticosteroids
- More than 15 days since prior radiotherapy
- More than 30 days since prior chemotherapy, or non-cytotoxic investigational agents
Exclusion Criteria:
- Active CNS metastases (i.e., progression of CNS disease during the past 30 days
without intervention)
- Evidence of coagulopathy, defined as PT and/or PTT more than 1.5 times ULN or
platelets more than or equal to 100,000/mm3.
- Evidence of leukoplakia, defined as absolute neutrophil count more than or equal to
1,500/mm3
- Evidence of respiratory failure (defined as SaO2 less than 90% on room air, PCO2 more
than 45 mm Hg, or FEV1 less than 1.0 L
- NYHA class III-IV within the past year
- Myocardial infarction within the past year
- Comorbid disease or medical condition that would impair the ability of the patient to
receive or comply with the study protocol
- Acute viral, bacterial or fungal infection that requires specific therapy
- HIV positive
- Hypersensitivity to any reagents used in the study
- Signs or sensitivity of acute adenoviral infection (i.e., conjunctivitis or
documented adenoviral upper respiratory infection)
- Pregnant or nursing
- Prior organ allograft