b. See above for schedule of tumor measurements. 
5. Safety Monitoring - Completion of Treatment 
Patients will be seen 4 and 8 weeks following the last vaccination, then every 
other month x 3, then every three months x 4, then every 6 months until 
progressive disease. An H/P, CBC, chem 20, and U/A will be done at each visit. 
Tumor measurements are scheduled 8 weeks following the last vaccination, and 
subsequently every scheduled visit as above. Blood will be drawn for 
serologic and CTL responses (see section VI) at the 4 and 8 week visit after 
the last vaccination, then at every scheduled visit. 
VII. Criteria for Response 
Complete remission (CR) - disappearance of all evident tumor (based on 
symptomatic, clinical, and radiographic resolution) and return of tumor- 
related abnormal tests to normal levels for a 28 day period. Abnormalities 
remaining which are believed not to represent tumor would require biopsy 
demonstrating the absence of malignant cells. 
Partial remission (PR) - a 50% or greater decrease in the sum of the cross 
sectional areas of all measured lesions, in the absence of progression of any 
lesion or appearance of any new lesions for a 28 day period. 
Stable disease (SD) - any change in measurable disease too small to meet the 
requirements of partial remission (50%) or progression (>25%) without new 
lesions . 
Progression (PD) - any of the following criteria: Development of any new 
lesion; increase of any previous single lesion by >50% in bidimensional 
diameter; new or progressive ascites, pleural effusions, jaundice, or decline 
in neurologic status not explained by other factors. Significant clinical 
deterioration related to malignant disease of two or more performance levels 
will be considered progressive disease. 
VIII. Criteria for Discontinuation of Treatment 
1. Progressive disease (see section V.5). 
2. Intercurrent illness which prevents further administration of 
treatment . 
3. Unacceptable toxicity. 
4. Decision of the patient to withdraw from the study. 
Recombinant DNA Research, Volume 18 
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