PROTOCOL THS 94-002 
REVISED 5 / 19/94 
PAGE 8 
3.2 Sterility will be assured by testing for aerobic and anaerobic bacteria, fungus, and mycoplasma. 
Other tests to be performed by Microbiological Associates, Rockville, MD include: 
Transmission EM for Viruses 
In Vitro Assay for Adventitious Viral Contaminants 
In Vivo Assay for Adventitious Viral Contaminants 
Isoenzyme & Cytogenetic Analysis 
Tumorigenicity,. 
EBV 
CMV 
Hepatitis 
HIV Co-Cultivation 
HTLV 1/2 PCR 
Adeno-Associated (AAV) Hybridization 
Parvovirus B-19 Hybridization Adenovirus 
4.0 PATIENT ELIGIBILITY 
4.1 Patients must have histologic proof of non-small cell lung cancer. Patients must be either unable to 
receive conventional treatment (e.g. the patient received radiation therapy for an unrelated cancer in 
the same field and has inadequate pulmonary function for surgery) or have failed conventional 
treatment. Patients need not have received a trial of chemotherapy prior to entering this protocol. 
4.2 Patients must have either an endobronchial tumor accessible by the bronchoscope, with some 
clinical evidence of bronchial obstruction, advanced local-regional cancer which is unresectable, or 
malignant pleural effusion. 
4.3 All patients must have a life expectancy of at least 12 weeks and must have a performance status of 
_<2 (Zubrod scale. Appendix B), 
4.4 All patients must sign an informed consent indicating that they are aware of the investigational 
nature of this study in keeping with the policies of the hospital. The only acceptable form is the one 
attached at the end of this protocol. 
4.5 A tumor biopsy must show a p53 mutation by single-strand conformation analysis^®. Material 
obtained previously and embedded in paraffin may be analyzed. If a new biopsy is required, the 
patient will be entered into the protocol and informed consent obtained if protocol entry is the sole 
reason for the biopsy. Mutations of the p53 gene will be determined by SSCP analysis of exons 5-8 
of PCR amplified tumor DNA. 
4.6 Patients will be tested for HIV prior to entry onto the protocol and must be HIV-negative. Patients 
with upper respiratory infections will not be treated until the infection resolves. 
4.7 Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte 
count of > 2,000/mm® and platelet count of 100,000/mm®), adequate liver function (bilirubin _<1 .5 
mg/dl), and adequate renal function (creatinine <1.5 mg/dl). 
5.0 TREATMENT PLAN 
5.1 The study will be an open-label upward dose ranging study for adenovirus-p53 vector (Ad5CMV- 
p53). 
5.2 The study will be done in two phases. It Is not known what toxicities If any will be caused by the 
adenovirus. The first phase of the study will allow assessment of toxicities related only to the vector. 
Patients will receive one Intratumor or intrapleural injection of Ad5CMV-p53. The initial dose will be 
10® plaque forming units (PFU). 
Recombinant DNA Research, Volume 19 
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