11.1.2 Childrens Hospital Los Angeles (CHLA), Division of Hematology-Oncology (H-0); 
-CHLA/H-0 will file all adverse drug reaction reports with the FDA within ten (10) days of the adverse drug 
reaction. A copy of all reports will be sent to the Study Committee. 
-CHLA/H-0 will coordinate actions to describe patient performance and compliance issues associated with treatment. 
This action will be initiated to determine needs for study modification. Upon indication, trials will be closed by the 
Study Chairman until analyses and evaluations are complete. 
11.2 Toxicity Criteria The CCG Toxicity Rating Scale is provided in Appendix III. Toxicities are to 
be reported on the appropriate data collection forms. 
12.0 RECORDS AND REPORTING 
12.1 Theradex Forms; Data for this study will be collected using the case report forms of Theradex, Inc. 
All data forms are to be provided to Dr. Seeger at the intervals specified below. The manual describing conventions 
for the completion of the case reports is available at CHLA/H-O. 
12.11 Filing Schedule 
12.11.1 History and Physical - within 7 days of telephone study entry. 
12.11.2 Prior Therapy -within 7 days of telephone study entry. 
12.11.3 Concomitant Measures - within 7 days of patient's final dose of EFN-_ transduced neuroblastoma cells. 
12. 1 1 .4 Study Drug Administration - within 7 days of patient's final dose of IFN-_ transduced neuroblastoma 
cells. 
12.11.5 Physician Notes - within 7 days of cessation of protocol mandated therapy. 
12.11.6 Course Assessment - within 7 days of the end of each course of protocol mandated therapy. 
12.11.7 Off Study Summary - within 7 days of the cessation of protocol mandated therapy. 
12.1 1.8 Flow Sheets - a set of flow sheets must be complete every 4 weeks while the patient is receiving 
protocol mandated therapy. The flow sheets must be mailed to Dr. Seeger's every four weeks. 
12.11.9 Pharmacokinetics and Urinary Excretion Form - Not applicable to this study. 
12.2 CCG Forms 
12.2.1 Specimen Transmittal Form 
This form is required with submission of blood and none marrow specimens. 
12.2.2 Disease Status and Event Form 
This form is to be submitted at yearly intervals, after a patient goes off protocol therapy, 
until the patient enters another therapeutic study, dies, or is lost to follow-up. 
12.2.3 Death Registration Form 
This form is designed to capture information regarding the death of a patient and is to be 
submitted to Dr. Seeger within two weeks of a patient's demise. 
14.0 REFERENCES 
1 . Young JL Jr., Miller RW. Incidence of malignant tumors in U. S. children. J Pediatr 1975; 86:254-258. 
2. Seeger RC, Reynolds CP. Treatment of high-risk solid tumors of childhood with intensive ther^y and 
autologous bone marrow transplantation. Pediatr Clin North Am 1991; 38:393-424. 
3. Tokiwa K, Iwai N, Ogita S, Hagiwara A, Sawai K, Takahashi T. [Evaluation of rational lymph node 
dissection for abdominal neuroblastoma]. Nippon Geka Gakkai Zasshi 1992; 
4. Evans AE, D'Angio GJ, Propert K, Anderson J, Hann HW. Prognostic factors in neuroblastoma. Cancer 
1987; 59:1853-1859. 
5. Hayes FA, Smith El. Neuroblastoma. Principals and Practices of Pediatric Oncology 1989; 607-622. 
6. Kushner BH, Cheung NK. Neuroblastoma. Pediatr Ann 1988; 17:269-76, 278. 
7. Reynolds CP, Selch MT, Seeger RC. Neuroblastoma. Cancer Treatment, 3rd Edition, WB Sanders 1990; 
489. 
8. Seeger RC, Brodeur GM, Sather H, Dalton A, Siegel SE, Wong KY, Hammond D. Association of 
multiple copies of the N-myc oncogene with rapid progression of neuroblastomas. N Engl J Med 1985; 
313:1111-1116. 
9. Goodenow RS, Vogel JM, Linsk RL. Histocompatibility antigens on murine tumors. Science 1985; 
230:777-783. 
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