myalgias and arthralgias will be recorded on the adverse events 
form using the National Cancer Institute (NCI) standardized 
grading system. Such symptoms may be disease related in this 
patient population. 
9.3 Treatment of Toxicity 
9.3.1 Discontinuation of GMT 
9.3. 1.1 Life threatening anaphylactic reaction secondary 
to GMT. 
9.3. 1.2 Any Grade El or Grade IV neurologic toxicity will 
result in withdrawal from study. NCI Toxicity 
Criteria will be used. 
9.3.2 Guidelines for reducing GMT schedule using the NCI 
Toxicity Criteria 
9.3.2. 1 Any adverse reaction will be recorded and 
evaluated by the investigator as to the severity 
according to the NCI Toxicity Criteria. The 
severity/grade of each adverse reaction will 
determine whether GMT is readministered and, 
if so, at what dosage level. 
9.3.2.2 For Grade III toxicities, GMT will be 
discontinued until the toxicity resolves to Grade 
I or pretherapy levels. Administration of the 
next GMT dose willl be at 50% of the initial dose. 
93 . 2.3 If Grade II or El toxicity occurs at this reduced 
dose, GMT will again be discontinued until a 
return to baseline or Grade I values. The next 
dosing may then be resumed at 10% of the 
original dose. 
9.3.2.4 However, any Grade II or III toxicity at this 
reduced dose will require withdrawal from 
study. 
9.4 Departure From The Protocol 
Protocol deviation will be approved in an emergency for 
individual situations for individual patients. The site will 
notify the sponsor immediately by telephone followed by written 
documentation: 
Applied Immune Sciences, Inc. 
(800)841-1407 (phone) 
(408)980-5888 (FAX) 
Ann Neale, B.S.N, R.N. 
Clinical Program Manager 
Annemarie Moseley, M.D., Ph.D. 
Vice President, Clinical Affairs 
Recombinant DNA Research, Volume 20 
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