Protocol HNS 94-001 
October 4, 1994 
Page 9 
Transmission EM for Viruses 
In Vitro Assay for Adventitious Viral Contaminants 
In Vivo Assay for Adventitious Viral Contaminants 
Isoenzyme & Cytogenetic Analysis 
Tumorigenicity c 
EBV 
CMV 
Hepatitis 
HIV Co-Cultivation 
HTLV 1/2 PC R 
Adeno-Associated (AAV) Hybridization 
Parvovirus B-19 Hybridization Adenovirus 
4.0 PATIENT ELIGIBILITY 
4.1 Patients must have histologic proof of squamous cell carcinoma of the head and neck. Patients must 
be either unable to receive conventional treatment (e.g. the patient received radiation therapy with or 
without surgery) or have failed conventional treatment. Those patients with extensive local or regional 
disease that have persisted or recurred following radiation therapy (with or without chemotherapy or 
surgery) and have clinically resectable, but likely non-curable (<10% disease free survival) are also 
eligible. Patients need not have received a trial of chemotherapy prior to entering this protocol. All 
eligible patients will be discussed at the Head and Neck Surgery Multidisciplinary Treatment Planning 
Conference prior to protocol enlistment. 
4 . 2 Patients must have clinical evidence of advanced local and/or regional cancer which is unresectable or 
for which no meaningful resection with surgical margins will be obtainable. 
4.3 All patients must have a life expectancy of at least 1 2 weeks and must have a performance status of <2 
(Zubrod scale, Appendix B). k 
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 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. 
4.6 Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte 
count of >2, 000/mm 3 and platelet count of 100,000/mm 3 ), adequate liver function (bilirubin ^1.5 
mg/dl), and adequate renal function (creatinine <1.5 mg/dl). 
4.7. Female patients of child-bearing potential are excluded. 
5.0 TREATMENT PLAN 
5.1 The study will be an open-label upward dose ranging study for adenovirus-p53vector (Ad5CMV- 
p53). 
5.2 The study will be done with two groups of patients. The two groups of patients will consist of a) 
resectable and b) non-resectable recurrent disease (Refer to 4.1). 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 injection of Ad5CMV-p53. The initial 
dose will be 10 6 plaque forming units (PFU). 
5.3 Three patients will be entered at each dose level with 6 patients entered at the maximum tolerated or 
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