Abstract
Recombinant interleukin-2 (rIL-2) was used to treat 31 patients with progressing metastatic malignant melanoma. Only three patients had disease confined to non-visceral sites; the median number of organ sites involved was four. The first dose of rIL-2 was given intrasplenically (to stimulate cytotoxic cells in high concentration) via a femoral artery catheter, and four further i.v. doses were given over 6 days. A total of three courses at 21-day intervals was planned. Doses were escalated in 15 patients from 1 x 10(6) to 16.4 x 10(4) Cetus units m-2. The maximum tolerated dose (11.0 x 10(6) U m-2) was used in the other 16 patients. Of the 71 courses, severe but transient toxicity requiring interruption of rIL-2 or additional care occurred on three courses (dyspnoea) and 15 from hypotension, but the patients' performance status improved. Four patients had partial tumour responses although in only one patient did response occur in all sites of disease. However, responses occurred in visceral sites and six patients are alive at 9-16 months. IL-2 is of use in advanced melanoma and does not need complicated ICU facilities.
Highlights
Thirty-one patients with metastatic, progressing melanoma were entered into the study which commenced in December 1986 and was completed 12 months later
Mild transient elevations of bilirubin up to three times normal occurred on five other courses
Patients were symptomatic from the fever for 1-4 h following Recombinant interleukin-2 (rIL-2)
Summary
Patient populationThirty-one patients with metastatic, progressing melanoma were entered into the study which commenced in December 1986 and was completed 12 months later. All patients had clinically evaluable disease and none had received antitumour treatment for at least 4 weeks before study entry. All patients had to have a Karnofsky score >50, be without major cardiovascular, respiratory system diseases and have no obvious CNS metastases ( routine CT brain scans were not performed). Fifteen patients with 62 metastatic sites (median four organ sites involved) entered a phase I escalating dose study. Two of these patients had solely non-visceral disease, i.e. limited to peripheral lymph nodes, skin and superficial soft tissues. The other 16 patients with 45 metastatic sites (median three organ sites involved) entered the phase II study with only one patient having non-visceral metastases
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