A phase-II trial of recombinant interleukin-2 and 5-FU chemotherapy in patients with metastatic colorectal carcinoma.

Seven patients with metastatic colorectal cancer have been treated with a regimen involving an 120-hour continuous infusion of rIL-2, 3 x 10(6) mu/m2. Entry restrictions included a Karnofsky index of greater than or equal to 80%, and a measurable lesion. One patient died of peritonitis secondary to bowel perforation at the site of the unresected tumour. One patient abandoned treatment following a pulmonary embolism during the first rIL-2 infusion. Other side effects included, pyrexia, rigors, nausea, hypotension, oliguria, weight gain, thrombocytopenia, neuropsychiatric symptoms and prerenal renal failure. Two patients have shown a greater than 50% regression in the size of their tumours and 3 have stable disease. The use of 'humanized' monoclonal antibodies together with mononuclear cells from patients receiving IL-2 infusions may provide a useful way of killing tumour cells which are resistant to lysis by LAK cells.