Protocol HNS 94-001 
October 4, 1994 
Page 2 of 2 
Patldlt Evaluati on. (Twenty lines not to exceed 75 character s per line) 
1 . A complete history and physical to include performance status, recent weight loss, usual weight and concurrent non-malignant 
disease and its therapy, and all prior anticancer treatments must be recorded. History and physical will be performed prior to each 
course. 
2. Laboratory studies shall include quantitative immunoglobulins; a CBC with differential and platelet count; SMA-12 and electro- 
lytes, including creatinine, bilirubin, SGPT, alkaline phosphatase, HIV analysis, urinalysis, chest x-ray, pre and post-treatment. 
3. All relevant information regarding viral dosage, tumor response, laboratory examinations, and treatment-related toxicities must 
be recorded before each treatment is given. 
4. Core biopsies or Incisional biopsies will be obtained of accessible local and or regional tumor. Tumor specimens will be 
collected 72 hrs. after the last injection of the adenovirus during the first treatment cycle. 
5. Biopsies will be analyzed for incorporation of the transduced gene into the host genomic DNA and expression of the transduced 
gene at the RNA level by standard hybridization techniques following polymerase chain reaction and by in situ hybridization. 
6. AU patients will be evaluable for response and toxicity following one course of therapy. 
7. A blood sample will be collected three times at one-half hour intervals following injection of the adenovirus. These samples will 
provide leukocytes to analyze for uptake of adenovirus DNA. Serum will be tested for antibodies to adenovirus proteins. Patients 
will be tested monthly during treatment, monthly for the first three months following completion of treatment, every three 
months for the remainder of the year following completion of treatment, and then at least yearly thereafter. 
8 . Normal tissue samples will be collected during the follow-up visits and endoscopies. These will include samples of non- 
malignant mucosa, leukocytes, and germ cells, if possible. These tissues will be analyzed for incorporation of the adenovirus. 
9 . A staging CT scan of the head and neck to evaluate local and regional disease will be obtained on an every three month basis 
during treatment. 
Miscellaneous Information: (Include any other information that you feel is pertinent to the study) 
(Three lines not to exceed 75 characters per line) 
Statistical Considerations: 
(Twelve lines not to exceed 75 characters per line] 
Three patients will be entered at each dose level with 6 patients entered at the maximum tolerated or 
maximum attainable dose (limitations imposed by production of the adenovirus). A maximum of 21 
patients will be entered into each study group, for a total of 42 patients for the entire study. 
Objectives: 
velvc lines not to exceed 75 characters per line) 
1 . To determine the maximum tolerated dose of the wild-type p53 adenovirus vector in patients with 
refractory NSCC. 
2. To determine the qualitative and quantitative toxicity and reversibility of toxicity of this treatment 
approach. 
3. To document observed antitumor activity of this treatment approach. 
Recombinant DNA Research, Volume 20 
[645] 
