rre-ujc, iUDmission: uinicai Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION , HYLAND DIVISION 
6. CLINICAL PROTOCOL 
6.1 PHASE 2 PROTOCOL 
6.1.1 INTRODUCTION 
The investigational device (the Neuroblastoma Bone Marrow Purging System) to be 
examined in the course of the proposed clinical study comprises: (a) a panel of murine 
monoclonal antibodies reactive with cell surface antigens found on neuroblastoma tumor 
cells; (b) a device, including its associated disposables, designed to remove paramagnetic 
microspheres added to marrow suspensions and (c) anti-murine antibody coated 
microspheres. It is intended that, when utilized in the therapeutic procedure described, 
this device will function ex vivo so as to remove con taminatin g neuroblastoma tumor cells 
from autologous bone marrow prior to infusion. 
The general principles of the investigational therapy are shown in Figure 6.1.1. 
Prior to and in concurrence with this proposed protocol, participating institutions will 
adhere to their own protocols using intensive combination chemotherapy regimens and 
drug therapies. These protocols will be summitted in the EDE in Section 6.4, Concurrent 
Clinical Protocols. 
6. 1.1.1 Neuroblastoma 
Pediatric neuroblastoma is a malignant tumor of sympathetic nerve cell origin, with the 
primary site of disease located in the adrenal glands (Friel, 1965). Neuroblastoma is 
staged according to a standardized set of criteria as Stage 1, 2, 3, or 4/4S, depending on 
the state of advancement of the primary tumor, and the presence or absence of metastatic 
disease. 
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