CBC, Differential, Platelets 
Urinalysis 
Pre 
X 
Every 6 
Twice Weeks and 
Weekly Weekly End of Study 
X 
X 
BUN, creatinine, uric acid, SGOT, X X 
SGPT, LDH, alkaline phosphatase, Na, 
K,C1, C0 2 , Mg, Ca, albumin, total protein, 
PT, PTT, cholesterol, glucose 
BUN, Creatinine, SGOT, Alkaline Phosphatase X 
Appropriate diagnostic images X X 
chest/bone x-ray, bone scan, CT 
or MRI) 
Bone marrow aspirate X X 
Peripheral Blood (20 ml)* XX X 
(Immunological/retrovirological) 
*10-20 ml of peripheral blood will also be obtained on alternate weeks for a 
further 6 weeks, then monthly for one year, and then annually for 10 years. Assessment 
of immunologic changes will be done for 1 year. Analysis for retrovirus/vector content 
by PCR and reverse transcriptase assay will be done for 10 years. 
7.3. Other tissues 
7.3.1 Punch biopsies of injection sites will be done prior to the second 
injection and 10-14 days after the second injection. 
8.0 EVALUATION DURING STUDY 
8.1 Follow-up Interval 
Patients shall be seen at 1-week intervals at St. Jude Children’s Research 
Hospital for 6 weeks, then on alternate weeks for 6 weeks then monthly for one 
year. Additional visits will be obtained as clinically indicated. The studies outlined 
in Section 7.2 shall be obtained weekly and prior to continuation of treatment. 
Recombinant DNA Research, Volume 15 
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