Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
antigens (detecting marrow progenitor cells and leukocytes, respectively), and positively 
stained with the UJ13A monoclonal antibody (directed against the neural cell adhesion 
antigen found on neuroblastoma cells). The polymerase chain reaction (PCR) and 
restriction fragment length polymorphism assays (RFLP) will be used to determine 
whether the sorted cells contain the marker genes, and whether both markers are present. 
Samples of marrow will also be grown in clonogenic assays and neuroblast colonies 
analyzed for the presence and frequency of each marker gene, to determine the 
clonogenic potential of the marked cells. (For details of methods, see Appendix C. The 
RFLP assays will be available for inclusion into the IDE document.) 
Based on a marrow relapse rate of 60% in the first year following transplantation 
(Anderson et al, 1991), 24 months of monitoring should allow us to obtain information 
regarding the safety of the device and the treatment plan, as well as the utility of gene 
marking for assessment of the efficacy of purging. 
6.1.4 PATIENT ELIGIBILITY 
6. 1 .4. 1 Inclusion Criteria 
1 . Male or female, age ^ 1 year 
2. Less than 21 years of age at initial diagnosis 
3. Stage D neuroblastoma in first or second marrow remission as evaluated by 
routine histology (see Appendix A for definition of stages and disease response 
criteria). 
4. Adequate performance status (Kamofsky greater than 70%) (See Section 6.4) 
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