toxicity at the 50% dose of IL-2. 
Cardiovascular toxicity : Patients developing Grade 3 cardiovascular 
toxicity during therapy will have treatment interruption. When cardiovascular 
toxicity returns to < 2 , therapy will be continued at the same dose level. If 
Grade 3 cardiovascular toxicity continues at this dose, then the dose of IL-2 
will be reduced by 50%, Patients will be removed from study for persistent or 
recurrent Grade 3 toxicity at the 50% dose of IL-2, Any patient with Grade 4 
toxicity will be removed from study. 
Neurotoxicity : Patients developing Grade 3 or worse neurotoxicity during 
therapy will have treatment Interruption, When neurotoxicity returns to < 2 , 
therapy will be continued at the same dose level. If Grade 3 or worse 
neurotoxicity continues, then the dose of IL-2 will be reduced by 50%, Patients 
will be removed from study for persistent or recurrent Grade 3 or worse toxicity 
at the 50% dose of IL-2, 
Cutaneous and allergy toxicity : Patients developing Grade 3 or worse 
toxicity during therapy will have treatment interruption. When toxicity returns 
to <3, therapy will continue at the preceeding dosage level. If Grade 3 or worse 
toxicity continues, then the dose of IL-2 will be reduced by 50%, Patients will 
be removed from study for persistent or recurrent Grade 3 or worse toxicity at 
the 50% dose of IL-2, 
6, Concommitant Therapy, Patients may receive concommitant medications to 
control the side effects of therapy. These medications have included: 
a. Acetaminophen 650 mg PO every 4 hours; 
b. Indome thac in 50 - 75 mg PO every 6 hours; 
c. Ranitidine 20 mg/hr intravenously continuously; 
d. Oxacillin Ig IV q 4 hours for prophylaxis of line sepsis; 
e. Mycostatin oral susp, 5 cc, swish and swallow every 12 hours 
f. Meperidine (25 - 50 mg) IV prn to control chills when they occur 
g. Hydroxyzine hydrochloride (25 mg PO every 6 hours prn) to 
treat pruritus 
h. A variety of antiemetics and antidiarrheals including 
loperamide, sandostatin and intravenous fluids 
i. When necessary low doses (<5ug/kg/hr) of phenylephrine and 
dopamine will be used to support blood pressure and urine output. 
j . Diuretics including furosemide and hydrochlorothiazide will 
be administered as needed to initiate diuresis, 
7. Schedule , Following the first cycle of therapy to tolerance (usually over 
3-5 days) and a period of rest, patients will receive an identical cycle 10-14 
days later. These 2 cycles of therapy will constitute a single course and may 
be repeated after 6-8 weeks if responses are noted or if there is stable disease 
after the first treatment course. Patients may continue therapy at 2-3 monthly 
intervals if progression or complete disappearance of lesions are not noted. 
Subsequent therapy will not Include more than three treatment courses. 
Recombinant DNA Research, Volume 14 
[843] 
