PROTOCOL THS 94-002 
REVISED 5/19/94 
PAGE 12 
bypass the adenovirus alone phase and Initially receive the adenovirus and cisplatin to establish the 
MTD for this combination. 
8.2 The tumor bed will be photographed prior to each course of therapy for endobronchial tumors. 
8.3 The longest diameter and its perpendicular will be measured will be determined for measurable 
lesions. Size will be reported as the product of the diameters. For pleural effusions reduction in the 
volume of the effusion and absence of malignant cells will be noted. Patients with pleural effusions 
or endobronchial tumors will not be considered evaluable for an objective response. 
8.4 The rate of regrowth of the tumor will be calculated from the above measurements. 
8.5 Patients will be evaluable for response if they had received at least one course of chemotherapy 
followed by an appropriate radiograph to document response. A complete response was defined as 
disappearance of all clinical evidence of tumor without the appearance of new lesions for a period of 
at least four weeks. Patients evaluable for a less-than-complete response must have had a 
bidimensionally measurable tumor. Partial response was defined as a 50% or greater reduction in 
the sum of the products of the diameters of the measurable disease; a minor response was defined 
as a 25% to less than 50% reduction In the sum of the products of the diameters of the measurable 
lesion. Patients were designated as having progressive disease If they showed a 25% or greater 
Increase In the size of their disease or If they developed unequivocal new lesions during treatment, 
and having no change if they had any tumor change not meeting the criteria described above. 
8.6 The time to progression will be measured from the first observation with reduction in tumor bulk until 
there is evidence of progressive disease. Progressive Disease is defined as an increase of ^ 25% in 
the sum of the products of the diameters of the measured lesion. Patients must have received at 
least two courses of therapy before a designation of progression is made. The survival of patients 
will be measured from entry into protocol. 
8.7 All toxicities encountered during the study will be evaluated according to the grading system (0-4) in 
Appendix C and recorded prior to each course of therapy. Duration of the toxicity and its treatment 
will -be recorded. Ufe-threatenlng toxicities should be reported immediately to the Study Chairperson, 
who in turn, must notify the IRB, RAC, and FDA. 
9.0 CRITERIA FOR DISCONTINUING THERAPY 
9.1 Presence of obstructing endobronchial tumor that has recurred after a minimum of 2 courses of 
treatment. 
9.2 The development of unacceptable toxicity defined as unpredictable, irreversible, or Grade 4 (non- 
hematologic). Patient refusal of therapy due to a specific toxicity should be graded as 4 and an 
explanatory note recorded. 
9.3 Non-compliance by patient with protocol requirements. 
9.4 Patient refusal to continue treatment. 
9.5 Criteria for removal from protocol: 
a) Refusal to continue study participation 
b) Significant hemoptysis 
c) Coagulopathy 
d) Progressive postobstructive pneumonia 
10.0 DATA AND PROTOCOL MANAGEMENT 
10.1 Protocol Compliance: The attending physician and oncology research nurse must see patients prior 
Recombinant DNA Research, Volume 19 [601] 
