TY - JOUR
T1 - Weekly 24-hour continuous infusion interleukin-2 for metastatic melanoma and renal cell carcinoma
T2 - A phase I study
AU - Perez, Edith A.
AU - Scudder, Sidney A.
AU - Meyers, Frederick A.
AU - Tanaka, Michael S.
AU - Paradise, Caroline
AU - Gandara, David R.
PY - 1991/2
Y1 - 1991/2
N2 - Twenty-nine patients with biopsy-confirmed metastatic melanoma (17) or metastatic renal cell carcinoma (12) were treated with escalating doses of recombinant human interleukin-2 (IL-2) administered as weekly 24-h intravenous infusions. Patients received from 3 to 12 × 106 C.U./m2 (18-72 × 106 I.U./m2) weekly over a treatment period of 1 to 16 weeks, with a median of eight weekly cycles administered. Patients in all treatment groups experienced non-life-threatening systemic side effects consisting of fever, nausea, vomiting, fluid retention, and diarrhea. Grade III hypotension was seen in four of six patients (67%) at 12 × 106 C.U./m2, and represented the dose-limiting toxicity. Grade IV hypotension occurred in 1 of 14 patients at 6 × 106 C.U./m2; no other grade IV toxicities were observed. Grade III fever occurred in 3 of 11 patients (27%) treated at 3 × 106 C.U./m2, 3 of 14 patients (21%) at 6 × 106 C.U./m2, and 3 of 6 patients (50%) at 9 × 106 C.U./m2. An objective response was observed in 3 of 28 evaluable patients (10%): 1 complete response and 1 partial response in renal cell cancer, and 1 partial response in a melanoma patient. We conclude that for future studies, the recommended dose of IL-2 given as a weekly 24-h infusion is 9 × 106 C.U./m2 and that a low rate of objective tumor response can be obtained in patients with melanoma and renal cell carcinoma using this regimen:
AB - Twenty-nine patients with biopsy-confirmed metastatic melanoma (17) or metastatic renal cell carcinoma (12) were treated with escalating doses of recombinant human interleukin-2 (IL-2) administered as weekly 24-h intravenous infusions. Patients received from 3 to 12 × 106 C.U./m2 (18-72 × 106 I.U./m2) weekly over a treatment period of 1 to 16 weeks, with a median of eight weekly cycles administered. Patients in all treatment groups experienced non-life-threatening systemic side effects consisting of fever, nausea, vomiting, fluid retention, and diarrhea. Grade III hypotension was seen in four of six patients (67%) at 12 × 106 C.U./m2, and represented the dose-limiting toxicity. Grade IV hypotension occurred in 1 of 14 patients at 6 × 106 C.U./m2; no other grade IV toxicities were observed. Grade III fever occurred in 3 of 11 patients (27%) treated at 3 × 106 C.U./m2, 3 of 14 patients (21%) at 6 × 106 C.U./m2, and 3 of 6 patients (50%) at 9 × 106 C.U./m2. An objective response was observed in 3 of 28 evaluable patients (10%): 1 complete response and 1 partial response in renal cell cancer, and 1 partial response in a melanoma patient. We conclude that for future studies, the recommended dose of IL-2 given as a weekly 24-h infusion is 9 × 106 C.U./m2 and that a low rate of objective tumor response can be obtained in patients with melanoma and renal cell carcinoma using this regimen:
KW - Interleukin-2
KW - Metastatic melanoma
KW - Metastatic renal cell carcinoma
KW - Phase I study
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U2 - 10.1097/00002371-199102000-00008
DO - 10.1097/00002371-199102000-00008
M3 - Article
C2 - 2012799
AN - SCOPUS:0025978347
SN - 1053-8550
VL - 10
SP - 57
EP - 62
JO - Journal of Biological Response Modifiers
JF - Journal of Biological Response Modifiers
IS - 1
ER -