6. 1 Treatment Modification and General Management of Toxicities 
• For any Grade 1 toxicity, there will be no dose modification. 
• If a Grade 2 toxicity develops, the investigator may elect to continue the 
treatment with careful monitoring or to hold the (drug) until values return 
to Grade l or less, then restart the drug. 
• In general, if a Grade 3 or 4 toxicity is obtained, the (drugs) will be held 
until a the Grade reaches <_ 1. Repeat tests to confirm values within 72 
hours will be required. 
• Any Grade 3 toxicity, thought to be related to IL-2 will necessitate a 50% 
dosage reduction. If Grade 3 toxicity persists for seven days or advances 
to grade 4 toxicity, IL-2 dose will be reduced to 10%. 
• For Grade 3 toxicity not related to IL-2, the investigators and 
collaborators will discuss the various options available. The appropriate 
action relative to the patient with a Grade 3 toxicity as well as a 
discussion of enrolling other patients will be addressed. Since no 
toxicities have been seen in other gene transfer protocols, precedence for 
the appropriate action is not available and will need to be decided on a 
case-by-case basis. 
6.2 Symptomatic Therapy for Toxicity 
Symptomatic therapy such as analgesics or other helpful therapy may be 
administered if deemed necessary by the participating investigators. All 
medications administered will be recorded in the appropriate Case Report Form. 
7.0 CRITERIA FOR DISCONTINUATION OF STUDY PATIENTS 
7.1 Criteria for Treatment Discontinuation 
Participation in this study can be discontinued for any of the following reasons 
listed below: 
7.1.1 At the Patient’s request: Any patient who wishes to withdraw from the 
study may do so but will be counselled that long-term follow-up for the 
effects of gene therapy are strongly desired by the medical facility and 
federal regulatory groups. 
7.1.2 A major, unexpected, or life-threatening toxicity requiring that treatment 
be discontinued 
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