Phase I study of high-dose continuous-infusion recombinant interleukin-2 and autologous lymphokine-activated killer cells in patients with metastatic or unresectable malignant melanoma and renal cell carcinoma.
The current study was undertaken to determine the maximum tolerated dose of recombinant interleukin-2 (rIL-2) that could be administered as a continuous infusion in conjunction with autologous lymphokine-activated killer (LAK) cells. All 55 patients in this study received a priming dose of rIL-2 of 1.0 mg/m2 per day given as a continuous infusion over 4.5 days. Patients later received (days 11-16) one of three doses of rIL-2 per day (1.0, 1.25, or 1.50 mg/m2) in conjunction with LAK cells given on days 11, 12, and 14. Because of unacceptable toxicity occurring early in the LAK cell phase of therapy at the rIL-2 dose level of 1.50 mg/m2, we concluded that the maximum tolerated dose of rIL-2 given as a continuous infusion with LAK cells is 1.25 mg/m2 per day.
Gaynor
E R
ER
Section of Hematology/Oncology, Loyola University Stritch School of Medicine, Maywood, IL 60153.
Weiss
G R
GR
Margolin
K A
KA
Aronson
F R
FR
Sznol
M
M
Demchak
P
P
Grima
K M
KM
Fisher
R I
RI
Boldt
D H
DH
Doroshow
J H
JH
D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000628:therapy*; D003131:Combined Modality Therapy; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000009:adverse effects / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000628:therapy*; D015979:Killer Cells, Lymphokine-Activated / Q000276:immunology*; D008297:Male; D008545:Melanoma / Q000628:therapy*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use
D007376:Interleukin-2; D011994:Recombinant Proteins