Abstract
Recombinant interleukin-2 (rIL-2) modified with monomethoxypolyethylene glycol (PEG IL-2) was utilized in patients with metastatic renal cell carcinoma in two separate multi-institutional trials. PEG IL-2 was administered as an I.V. bolus days 1, 8, 15, and 22 with cycles repeated every six weeks. The two trials employed different dose levels: A) 20x106 I.U./m2 day 1 followed by 12x106 I.U./m2 days 8, 15, 22; and B) 12x106 I.U./m2 days 1, 8, 15, 22. Thirty-five patients were entered and 31 were evaluable for response (A-15/18, B-16/17). Two of 31 patients had partial responses. Median therapy duration was four weeks (range 1-15), and dose reduction for grade III or IV toxicity was required in 14/35 patients (A-6/18, B-8/17). Toxicity (≥ grade III) seen included: hypotension 51%, dyspnea 17%, seizures 6%, and mental status changes 11%. No differences in response or toxicity between the two schedules were noted. Hematologic changes included lymphocytosis and eosinophilia in the majority of patients. PEG IL-2 given once weekly has significant toxicity, and may produce tumor regression in patients with renal cell carinoma.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 211-217 |
| Number of pages | 7 |
| Journal | Investigational New Drugs |
| Volume | 11 |
| Issue number | 2-3 |
| DOIs | |
| State | Published - Jun 1993 |
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Keywords
- PEG IL-2
- phase II trial
- renal cell carcinoma
ASJC Scopus subject areas
- Pharmacology
- Molecular Medicine
Cite this
Polyethylene glycol conjugated interleukin-2 : Clinical and immunologic effects in patients with advanced renal cell carcinoma. / Bukowski, Ronald M.; Young, James; Goodman, Gary; Meyers, Frederick J; Issell, Brian F.; Sergi, James S.; McLain, Denise; Fyfe, Gwen; Finke, James.
In: Investigational New Drugs, Vol. 11, No. 2-3, 06.1993, p. 211-217.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Polyethylene glycol conjugated interleukin-2
T2 - Clinical and immunologic effects in patients with advanced renal cell carcinoma
AU - Bukowski, Ronald M.
AU - Young, James
AU - Goodman, Gary
AU - Meyers, Frederick J
AU - Issell, Brian F.
AU - Sergi, James S.
AU - McLain, Denise
AU - Fyfe, Gwen
AU - Finke, James
PY - 1993/6
Y1 - 1993/6
N2 - Recombinant interleukin-2 (rIL-2) modified with monomethoxypolyethylene glycol (PEG IL-2) was utilized in patients with metastatic renal cell carcinoma in two separate multi-institutional trials. PEG IL-2 was administered as an I.V. bolus days 1, 8, 15, and 22 with cycles repeated every six weeks. The two trials employed different dose levels: A) 20x106 I.U./m2 day 1 followed by 12x106 I.U./m2 days 8, 15, 22; and B) 12x106 I.U./m2 days 1, 8, 15, 22. Thirty-five patients were entered and 31 were evaluable for response (A-15/18, B-16/17). Two of 31 patients had partial responses. Median therapy duration was four weeks (range 1-15), and dose reduction for grade III or IV toxicity was required in 14/35 patients (A-6/18, B-8/17). Toxicity (≥ grade III) seen included: hypotension 51%, dyspnea 17%, seizures 6%, and mental status changes 11%. No differences in response or toxicity between the two schedules were noted. Hematologic changes included lymphocytosis and eosinophilia in the majority of patients. PEG IL-2 given once weekly has significant toxicity, and may produce tumor regression in patients with renal cell carinoma.
AB - Recombinant interleukin-2 (rIL-2) modified with monomethoxypolyethylene glycol (PEG IL-2) was utilized in patients with metastatic renal cell carcinoma in two separate multi-institutional trials. PEG IL-2 was administered as an I.V. bolus days 1, 8, 15, and 22 with cycles repeated every six weeks. The two trials employed different dose levels: A) 20x106 I.U./m2 day 1 followed by 12x106 I.U./m2 days 8, 15, 22; and B) 12x106 I.U./m2 days 1, 8, 15, 22. Thirty-five patients were entered and 31 were evaluable for response (A-15/18, B-16/17). Two of 31 patients had partial responses. Median therapy duration was four weeks (range 1-15), and dose reduction for grade III or IV toxicity was required in 14/35 patients (A-6/18, B-8/17). Toxicity (≥ grade III) seen included: hypotension 51%, dyspnea 17%, seizures 6%, and mental status changes 11%. No differences in response or toxicity between the two schedules were noted. Hematologic changes included lymphocytosis and eosinophilia in the majority of patients. PEG IL-2 given once weekly has significant toxicity, and may produce tumor regression in patients with renal cell carinoma.
KW - PEG IL-2
KW - phase II trial
KW - renal cell carcinoma
UR - http://www.scopus.com/inward/record.url?scp=0027244915&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0027244915&partnerID=8YFLogxK
U2 - 10.1007/BF00874158
DO - 10.1007/BF00874158
M3 - Article
C2 - 8262734
AN - SCOPUS:0027244915
VL - 11
SP - 211
EP - 217
JO - Investigational New Drugs
JF - Investigational New Drugs
SN - 0167-6997
IS - 2-3
ER -