8.2 Early Termination of Study and Modifications of Drug Dosages 
8.2.1 This study will be complete when the maximum injectable dose (6.1.5) 
has been reached. 
8.2.2. Therapy for an individual patient can be terminated if a dose limiting 
toxicity has been observed. 
8.2.3 If the patient/parent desires to withdraw from the study, or if the 
physician feels that it is in the patient’s best interest, treatment will be 
discontinued. 
8.2.4 If Grade 3/4 toxicity is encountered in these studies, the Institutional 
Review Board will be notified and dosage modifications made before 
admission of additional patients to confirm the maximum tolerated dose. 
8.2.5 If no Grade 3/4 toxicity (see Appendix A) is encountered, dosage 
escalations will proceed as outlined. 
8.3 With complete or partial response, or stable disease activity, delivery of therapy 
will be offered for two further injections (see Section 6.0). 
8.4 The criteria listed in Appendix A will be used in grading toxicity. 
8.5 For consistency, toxicity for all patients will be quantitated using these criteria 
at the end of the trial. 
8.6 A 4 week period will constitute a course which will be evaluated for critical 
toxicity, and a 6 week period will be required for evaluation for antitumor activity 
and for late toxicity. 
9.0 CRITERIA FOR RESPONSE AND STATISTICAL CONSIDERATIONS 
9.1 As in all Phase I protocols, therapeutic intent is expected. 
9.2 Since this is a Phase I study, primary consideration will be given to 
determinations of the qualitative and quantitative toxicity and immunologic 
efficacy. Time of onset of toxicity and extent of toxicity will be noted and 
recorded in the following categories: local skin reactions (including biopsy 
proven evidence of local tumor cell growth): fever nausea; vomiting; diarrhea; 
anorexia; mucosal ulcerations; anemia; leukopenia; thrombocytopenia; 
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