Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
5. Laboratory parameters: 
a) Renal function: creatinine < twice normal for age 
b) Cardiac function: ejection fraction > 35 % on echocardiography 
c) Hepatic function: SGOT or SGPT <3x normal, bilirubin < 1.5mg/dl 
6. Autologous marrow without histologic evidence of tumor involvement available 
for reinfusion. 
7. Written informed consent (Section 6.3.9) conforming to institutional guidelines 
obtained from patient and/or parent or guardian. 
6. 1.4.2 Exclusion criteria 
1 . Serious localized or systemic infection 
2. HIV positivity 
3. < 2.5 x 10 8 /kg marrow mononuclear cells obtained at harvest excludes the 
patient from the gene transduction study*. 
* To ensure that sufficient aliquots of marrow can be removed for transduction without 
potentially compromising the rate of hematological engraftment, the minimum quantity of 
marrow mononuclear cells to be obtained at harvest will be raised above the minimum value 
used in most neuroblastoma protocols. Should this safety margin not be attainable, the 
patient will be ineligible for the transduction study. 
6.1.5 STUDY CONDUCT 
6. 1 .5. 1 Description of Neuroblastoma Bone Marrow Purging System 
Recombinant DNA Research, Volume 16 
[461] 
