The following monitoring schedule will be used: 
every 
other 
Pre-Studv d 2-7 d7-20 d3Q Q weekly week Q monthly 
Qday CCD x4 x2 
History and Physical Exam 
X 
X 
X 
X 
X X 
Weight 
X 
X 
X 
X 
X X 
Performance Status 
X 
X 
X 
X 
X X 
CBC, Platelets, Diff 
X 
X 
X 
X 
X X 
BUN, Creatinine 
X 
X 
X 
X 
X X 
Calcium 
X 
X 
X 
X 
X X 
Bilirubin, SGOT, SGPT 
X 
X 
X 
X 
X X 
Alkaline Phosphatase 
X 
X 
X 
X 
X X 
Chest x-ray 
X 
X 
X 
X 
Chest CT Scan 
X 
X-then every 
2 months 
Arterial Blood Gas 
xi 
EDG 
xi 
Urinalysis 
xi 
Abdominal CT Scan 
X 2 
Bone Scan 
X 3 
Bone Radiographs 
X 4 
Head CT/MRI 
X 5 
Thoracentesis 2 
Tests for viral shedding 
X 
X 
X 
X 
X X 
Immune Response Tests 
X 6 
1 repeated if clinically indicated 
2 performed if clinically indicated 
3 optional, unless patient is symptomatic or alkaline phosphatase is elevated 
4 if bone scan is positive 
5 only if symptoms suggest intracranial metastasis 
3 blood will be obtained for serological analysis and measurement of cell mediated immunity on 
Days 7, 14, 20, 28 and q monthly x 4 afterwards 
V.C.4. Evaluation of Therapy 
The patients will be carefully monitored for toxicity, virus shedding, immunological 
response to HSVf/c protein or adenoviral proteins and efficiency and stability of gene transfer . 
Although, the phase I trial was not designed to evaluate efficacy, we will obviously closely follow the 
clinical response to the tumor. 
1. Systemic toxicity: Serial examinations will include history and physical examination, routine 
vital signs, temperature, and body weights. We will frequently measure blood chemistries, 
hematologic, and coagulation parameters. 
2. Thoracic toxicity: Serial chest radiographs and chest physical exams will be performed. Any 
complaints or abnormalities will be evaluated by arterial blood gases, CAT or MRI scans, and 
pulmonary function tests if clinically indicated. We will be focusing particularly on evidence of 
pleural infection or inflammation. If pleural effusions appear or persist, a sample will be removed 
by thoracentesis and the fluid analyzed for microbacterial growth, cellular content, cytology, etc. In 
addition, pleural fluid will be analyzed for evidence of immune activation and of gene transfer. 
Recombinant DNA Research, Volume 20 
[407] 
