Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
* Select all patients in accordance with the selection criteria outlined in Section 
6.1.4. 
* Ensure that current FDA cGCP regulations are followed. 
* Treat patients as described in this research protocol until such time as the 
patient leaves the study. 
* Obtain Institutional Review Board approval for the protocol and informed 
consent form prior to beginning the study. 
* Complete .all case report forms, review for accuracy and completeness, and 
provide the original clinical report forms with a clinical summary to the 
Clinical Monitor, Baxter Healthcare Corporation, Immunotherapy Division. 
* Ensure strict adherence to the protocol with regards to proper collection and 
documentation of the required data and required laboratory samples, ensure 
that the product is kept in a secured area, and ensure that all enrolled patients 
receive and sign written informed consent forms prior to their participation in 
the study. 
* Maintain study records for a period of 2 years after market approval is 
received or 2 years after clinical and product development are discontinued and 
the FDA notified. 
Principal Investigators: Victor M. Santana, M.D.; Malcolm K. Brenner, M.B., Ph.D., 
F.R.C.P., M.R.C. Path.; James Ihle, Ph.D.; St. Jude Children’s Research Hospital, 
Memphis, TN 
Co-investigators: Tom Moss, M.D., Cedars-Sinai Hospital, Los Angeles, CA. 
Recombinant DNA Research, Volume 16 
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