Abstract
A phase‐1/II study of recombinant interleukin 2 (rIL‐2) was performed in 31 melanoma patients. The first dose of rIL‐2 was given intrasplenically followed 4 hr later by an i.v. dose and 3 further i.v. doses on alternate days. Three courses of treatment were planned at 3‐week intervals. The maximum tolerated single dose was 11 × 106 Cetus U/m2. Haematological and immunological data were available on 20 patients. Post‐treatment response to rIL‐2 therapy was evident from (i) a rapid depletion of peripheral blood lymphocytes (PBL) with a rebound at 4–7 days (2 times pre‐treatment values); (ii) an increase in the number of IL‐2 receptor‐positive lymphocytes (4–15 times pre‐treatment values); (iii) an increase in the number of “positive” patients with cytotoxic (anti‐K562) peripheral blood mononuclear cells (PBMC) from 30% to 80%; (iv) amplified killing of K562 by positive patients in relation to pre‐treatment values; and (v) the induction of PBMC cytotoxicity (in 45% of patients) against the NK‐resistant, LAK‐sensitive target, Mel 1. Partial clinical responses to rIL‐2 treatment were observed in 4 patients, but these were not reflected in the PBMC LAK activity or the other parameters examined.

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