4.0 TREATMENT PROGRAM 
4.1 Treatment: Two groups of patients, as defined in 3.1, will be immunized. Immunizations will be 
given on weeks 0, 2, 4, 8, 12, 24, and 36 unless the patient is removed from the protocol (see 7.0). 
4.2 Dose Escalation 
4.21 Inter-Patient Escalation: A given patient will receive the same dose of cells at each immunization. 
Three patients will be entered per dose level for each group of patients (Groups 1 and 2). 
Escalations are as follows: 
level 1: lx 10^ cells/m^/dose 
level 2: 5 X 10^ cells/m^/dose 
level 3: 10 x 10^ cells/m^/dose 
The potential systemic dose of IFN-y over 4 days will not exceed 10% of its MTD when given parenterally. Each 
immunizing dose will be divided into two subcutaneous injections and alternately given below the inguinal and 
axillary areas. Unless toxic effects suggest otherwise, autologous and allogeneic vaccines will be considered the 
same for the purposes of dose escalation. 
Table 1. Dose escalation schema. 
No. Pts. with Events 
at Current Dosc^ 
Change in Dose Level Based on No. Events 
0/3 
Advance to next higher level 
1/3 
Accrue three more patients, for total of 6 evaluable 
patients 
1/6 
Do not advance, do not decrease 
2/6 
Decrease dose to next lowest level 
2/3 
Decrease dose to next lowest level 
^An event is a treatment related death or a grade 3 or 4 toxicity. 
If known cytokine related toxicity is observed, the dose will be reduced to the previous level or, if necessary, discontinued. 
4.22 Intra-Patient Escalation . There will not be intra-patient dose escalation. 
4.3 Dose Limiting Toxicity; The MTD for IFN-y transduced neuroblastoma cells will be defined as 
the highest dose that is tolerated by ^ of 3 (or 4 of 6) patients receiving that dose without evidence of grade 3 or 4 
toxicity that is not reversible within 28 days of tumor cell injection (CCG Toxicity Rating Scale, Appendix L). 
The most common adverse effects from IFN-y are flu-like symptoms, fever and fatigue. 
4.4 Concomitant Therapy 
4.4.1 No other systemic cancer therapeutic agents are allowed. 
4.4.2 Radiotherapy to localized painful lesions is acceptable, provided at least one measurable lesion is not 
irradiated. Any irradiated lesion can not be used to assess tumor response. 
4.4.3 Appropriate antibiotics, blood products, antiemetics, fluids, electrolytes and general supportive care are 
to be used as necessary. 
Recombinant DNA Research, Volume 19 
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