7.3. Other tissues 
7.3.1 Punch biopsies of appropriate skin sites, GI tract or liver biopsies will 
be done if the patient should develop GVHD. 
8.0 EVALUATION DURING STUDY 
8.1 Follow-up Interval 
Patients shall be seen at thrice weekly intervals at St. Jude Children's Research 
Hospital for 6 weeks, then weekly for 6 weeks then monthly for one year. 
Additional visits will be obtained as clinically indicated. 
8.2 Early Termination of Study and Modifications of Drug Dosages 
8.2.1 This study will be complete when 3-6 patients have been entered at 
each dose level (See Section 9). 
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. 
8.3 The criteria listed in Appendix II will be used in grading toxicity. 
8.4 For consistency, toxicity for all patients will be quantitated using these criteria 
at the end of the trial. 
8.5 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 STATISTICAL CONSIDERATIONS 
9.1 Design (stopping rule) 
When three of the first three (or five of the first six) patients have successfully 
completed a dose level without evidence of dose limiting toxicity (DLT) 
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