10.2 Partial Response (PR): By physical examination or radiography (including 
CT scan and/or ultrasound) , the patient maintains for a minimum of four weeks 
a decrease of over 50% in the sum of the perpendicular diameters of all 
measured lesions. No simultaneous increase in size of any lesion nor 
appearance of any new lesion may occur. 
10.3 Minor Response (MR): 25-49% decrease in the summed products of diameters 
of measured lesions for a minimum of four weeks. 
10.4 Stable Disease (SD) : Less than 25% decrease or increase in tumor size for 
at least three months. 
10.5 Progression (PROG): Greater than 50% increase in the sum of all measured 
lesions, or appearance of new lesions. Note that if there is the appearance 
of superficial cutaneous, subcutaneous, or soft tissue disease < 2 cm 
diameter, the patient may continue with immunizations at the discretion of the 
investigator . 
10.6 Duration of Response: Measured from initiation of therapy until a 50% or 
greater increase from the smallest sum of all tumor measurements obtained best 
response (CR, PR, MR) . 
11.0 Criteria For Toxicity 
Toxicity will be graded and classified according to Common Toxicity 
Criteria (clinical protocol Appendix I) by the following outline: 
0 No toxicity 
1 Mild toxicity, usually transient, requiring no special treatment 
and generally not interfering with usual daily activities. 
2 Moderate toxicity ameliorated by simple maneuvers. 
3 Severe toxicity which requires therapeutic intervention and 
interrupts usual activities. Hospitalization may or may not be required. 
4 Life-threatening toxicity which requires hospitalization. A 
toxicity which causes a drug-related death will be called a 4F. 
12.0 Adverse experience 
To date, there have been minimal or no reported side effects from 
immunizations with allogeneic tumor cells (43) . Patients have experienced 
induration and erythema at the immunization site. Anaphylaxis has not 
occurred. Growth of (non irradiated) allogeneic cellular immunogens has not 
been observed. (In this study, the cells are subjected to 5,000 rads before 
injection. There were no surviving cells in vitro following this dose of X- 
irradiation . ) In the initial reported study of the administration of 
genetically altered human cells to patients, no additional adverse effects 
were reported (32) . 
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