I 
9.1.8 Finally, every attempt will be made to excise tumor tissue prior to treatment for 
diagnosis, immunochemistry, cryo-preservation and to evaluate delayed-type 
hypersensitivity reactions to the tumor before and after treatment. 
9.2 Clinical Response Criteria 
All patients who receive at least one dose of study drug will be analyzed for efficacy 
and safety. Standard oncologic criteria will be applied to determine whether or not a 
patient responds to the study drug. All tumor measurements must be recorded in 
centimeters and should consist of the longest diameter and the perpendicular diameter 
at the widest portion of the tumor. All the following determinations of tumor response 
should be made comparing current total tumor size to pre-treatment total tumor size. 
9.2.1 Complete Tumor Response 
Disappecirance of all clinical evidence of active tumor for a minimum of four weeks. 
The patients must be free of all symptoms of cancer. 
9.2.2 Pcirticd Tumor Response 
Fifty percent (50%) or greater decrease in the sum of the products of all diameters of 
mecisurable lesions. These reductions in tumor size must endure for a minimum of four 
weeks. No simultaneous increase in the size of any lesion or appearance of new lesions 
may occur. The appropriate diagnostic tests used to demonstrate the response must be 
repeated four weeks after initial observation in order to document this duration. 
9.2.3 Stable Disease 
Less than 50% decrease in the sum of the products of all diameters of measurable 
lesions, or an increase in the tumor mass less than 25% in the absence of the 
development of new lesions. 
9.2.4 Progressive Disease 
Tumor progression will be defined if one or more of the following criteria are met 
o Appearance of any new lesion(s). 
o Increase in tumor size of > 25% in the sum of the products of all diameters 
of measurable lesions. 
o Significant cliniccil deterioration that cannot be attributed to treatment or 
other medical conditions and is assumed to be related to increased tumor 
burden. 
o Worsening of tumor-related symptoms clinically significant by physician. 
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