A Phase I study of recombinant human interleukin-2 and alpha-interferon-2a in patients with renal cell cancer, colorectal cancer, and malignant melanoma

Experiments in several mouse models of human cancer suggest that synergy occurs with the combination of interleukin-2 (IL-2) and alpha-interferon (alpha IFN). That is, the combination of the two agents is more effective than the sum of their individual anticancer activities. A clinical trial was conducted to determine the maximum dose of the combination that could be tolerated by human patients with a variety of different cancers. The toxic effects of fatigue, diarrhea, low blood pressure, fluid retention, and anorexia limited the dose of the combination to 5 million units per meter squared of body area of interleukin-2 per day, and 6 million units per meter squared of alpha interferon per day. One patient suffered a cardiac arrest, which is considered to represent Grade IV toxicity. Less than half the patients experienced Grade III toxicity; 33 percent had non-life-threatening Grade III toxicity, and 13 percent developed life-threatening Grade III complications in the lungs or nervous system. The drug combination was found to have no measurable beneficial effect on melanoma, lymphoma, and colorectal cancer. However, 4 of 18 patients with kidney cell cancer showed a partial response to the combination treatment. (Consumer Summary produced by Reliance Medical Information, Inc.)