Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
treatment. A second additional document of informed consent specific to the gene 
marking/purging procedures must also be signed by all patients and/or their legal 
guardian. This document must also be consistent with local institutional and federal 
guidelines and must indicate the investigational nature of this protocol as well as possible 
side effects. Further, patients must be informed that no efficacy of this therapy is 
guaranteed, and that unforseen toxicities may occur. Patients have the right to withdraw 
from this protocol at any time. No patient will be accepted for treatment without such 
a document signed by him or his legal guardian. 
Patients may be asked to volunteer for other appended or ancillary protocols which 
investigate other questions such as issues of supportive care, the use of hematopoietic 
growth factors, management of infectious diseases and/or their prophylaxis, and 
pharmacokinetic studies. In circumstances where such protocols are approved, a separate 
informed consent document, consistent with the above guidelines, will be obtained. 
If there is conflict between the parent’s and child’s wishes, patients will have an 
opportunity to discuss the proposal with a representative from the social services or 
psychology departments who will serve as a patient advocate and who should also witness 
the consent. 
A copy of the signed consent form will be retained with case report form during the 
study; following completion of the study, the signed consent form will be retained with 
the trial register. 
The informed consent for gene marking and purging, which will be obtained in addition 
to the informed consent for the chemoradiotherapy and bone marrow transplantation 
procedure, follows. 
Recombinant DNA Research, Volume 16 
[489] 
