COMBINED LEVAMISOLE WITH RECOMBINANT INTERLEUKIN-2 (IL-2) IN PATIENTSWITH ADVANCED RENAL-CELL CARCINOMA - A PHASE-II STUDY

Adoptive immunotherapy (AI) with interleukin-2 (IL-2) and lymphokine-a ctivated killer (LAK) cells is an antineoplastic modality in which imm une-activated cells are administered to a host having cancer in an att empt to mediate tumor regression. Levamisole (LEV), an immune stimulan t, has been suggested as having therapeutic effectiveness in a variety of cancers. After a phase I trial of recombinant IL-2 plus LEV, a pha se II trial of this combination was conducted in patients who had adva nced renal cell carcinoma. The regimen was IL-2 at 3 x 10(6) U/m(2) da ily x 5 plus LEV at 50 mg/m(2) perorally three times a day x 5. Only o ne of the 22 eligible patients had a regression. It was a partial regr ession, 85 days in duration. The median time to treatment failure (ref usal, progression, or off study because of toxicity) was 36 days. The only grade 4 toxicity reported was lethargy. This regimen is not recom mended for further testing in patients who have advanced renal cell ca rcinoma.