eight hours. Many of the side effects of the therapy were attributable to the rIL-2 infusions and 
resolved rapidly upon cessation of the rIL-2. Rosenberg reported on 20 study subjects with 
metastatic malignant melanoma who received a single dose of cyclophosphamide followed 36 
hours later by infusions of TIL. The patients received infusions of TIL ranging from 3 x 10 10 
to 75 x 10 10 cells (median 20.5 x 10 10 ) over a period of one to two days without notable adverse 
experiences. After the first infusion. study subjects also received an infusion of 100,000 units 
of rIL-2/kg given every eight hours for five days or until dose- limiting symptoms occurred 8 . 
10.6 Treatment of Possible Toxicity and Side Effects of TIL 
Toxicity associated with infusion of autologous TIL has not been observed, 
however, there is the theoretical potential that patients may experience chills, 
fever, nausea and general malaise seen infrequently with the transfusion of blood 
components. Symptoms may mimic those of rIL-2 and should be treated 
according to the treatment regimen in Section 10.2.2. 
1 1 . EVALUATION OF SAFETY AND EFFICACY 
11.1 Baseline Evaluation 
The clinical investigator will complete a physical examination. The following 
criteria will be evaluated within 2 weeks prior to the initiation of therapy: 
Physical exam, including weight, Kamofsky Performance status, and vital signs 
Concomitant medications 
CBC with differential, platelet count 
Serum chemistry 
Urinalysis 
Coagulation profile (PT, PTT) 
Tumor assessment measurements of evaluable disease by appropriate diagnostic, 
radiological and nuclear medicine studies 
Pregnancy test (if premenopausal female) one week prior to therapy 
Cytokine assays (serum IL-2 and alpha interferon) 
Antibody assays (anti-rIL-2 and anti-rHuIFN-alpha 2a) 
Cytotoxicity of peripheral blood cells (K562, Daudi, LDCC) 
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Recombinant DNA Research, Volume 15 
