Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
Because patients in this study will receive unpurged marrow as well as purged marrow 
and because most or all will receive growth factors, it is likely that our time to marrow 
recovery will be better than 43 days. Due to the small sample size, however, it is likely 
that statistical comparisons will not be informative. 
6.2.2.3 Toxicity 
Toxicity will be monitored and graded according to the National Cancer Institute 
Common Toxicity Criteria as described in Appendix B. 
6.2.3 EFFICACY 
6.2.3. 1 Device Performance 
The performance of the device will be measured by its ability to remove tumor cells from 
harvested, marked marrow. The following tests will be performed on the marrow cell 
suspensions immediately before and after the purging procedure: 
immunofluorescent staining and cell sorting for detection and separation of 
neuroblasts 
immunocytologic analysis for the detection of neuroblasts 
clonogenic assay for neuroblasts and analysis of clones by PCR for presence 
of the marker 
where possible, clonogenic assays for neuroblasts and analysis for the presence 
of markers will also be attempted on cells removed from the marrow during 
the purging procedure and subsequently recovered from the beads 
As indicated in Section 6. 1.2.2, performance of the device will be established by 
demonstrating tumor cell removal to undetectable levels by immunocytology from 
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