Criteria for defining number of patients at each dosage level, maximum tolerated 
dosage and dose limiting toxicity are noted in Section 10.1 
10.0 OFF-STUDY CRITERIA 
10.1 Any patient who develops irreversible life-threatening non-hematologic organ 
system dysfunction or local tumor growth (toxicity grade 3 or 4) considered to 
be primarily related to tumor injection will be removed from this protocol and 
will not be eligible for subsequent treatment with gene modified tumor cells. 
De-escalation will be permitted for patients who have reversible Grade 3/4 
toxicity if these individuals have evidence of complete, partial or mixed response, 
or stable disease. 
10.2 Increasing disease after one course of therapy, including tumor cell growth at 
injection site. 
10.3 Any patient whose disease process stabilizes or regresses will be offered further 
injections of IL-2 modified cells at the dose level previously administered. 
10.4 Any questions regarding patients on this study should be addressed to Dr. 
Furman (Ext 2403) or Dr. Brenner (Ext 410). 
11.0 RECORDS TO BE KEPT 
Flow sheets documenting dates and doses of therapy as well as clinical chemistries, 
hematologic parameters, the clinical status and occurrence of any adverse events and 
subsequent interventions are to be kept on all patients. 
Imaging reports 
Surgical summaries 
Autopsy summaries, where appropriate 
Date of entry on to other appended protocols 
Informed consent documents 
All required clinical evaluation records will be the responsibility of Dr. Victor Santana 
who will also be responsible for analysis of the clinical outcome and toxicity. 
Recombinant DNA Research, Volume 15 
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