4.9 DISCONTINUATION OF THE ACTIVE IMMUNIZATION SCHEDULE: 
A. Therapy will be discontinued if grade 3 or 4 toxicity occurs. 
B Therapy will be discontinued if the patient refuses further treatment for any 
reason, including intolerable subjective toxicity. 
C. Therapy will be discontinued if the disease progresses sufficiently to cause 
symptoms that require other treatments. 
D. Therapy will be discontinued for patients who have continued rapidly 
progressive disease. 
E. Following the enrollment of an initial 10 patients, if 0/10 demonstrate an 
increase in CTL above pretreatment levels, and barring objective evidence of 
tumor regression, the protocol will be discontinued. 
4.10 TOXICITY: 
A. All toxicities and adverse reactions will be recorded in the case report form. 
All adverse reactions will be reported to the Institutional Review Board. 
B. Possible immediate side effects from the injections may include allergic 
reactions such as rash, skin tenderness, swelling, fever, or hives. Also possible 
at the site of injection is granuloma (lump) formation. Rarely, more severe 
allergic reactions could occur, such as severe shortness of breath, low blood 
pressure or fainting. The transduced autologous tumor cells could conceivably 
contain viruses undetectable with current testing procedures which could be 
infectious. 
C. The Investigator will observe good clinical practice in the assessment and 
management of toxicity to treatment. 
4.11 PATIENT FOLLOW UP: 
A. All patients will be followed for 36 months from the time of first treatment 
or until death. 
B. If deemed necessary to monitor the duration of an objective clinical response, 
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