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Phase I Trial of Recombinant Human -Interferon and Recombinant Human Tumor Necrosis Factor in Patients with Advanced Gastrointestinal Cancer

Departments of Medical Oncology [J. L. A., B. L. J. A. A., J. S. F., Y. Z. P., C. E.], Clinical Immunology and Biological Therapy [K. E., J. U. G.], Division of Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, and Genentech Inc., South San Francisco, California [S. S.]

Recombinant human -interferon and recombinant human tumor necrosis factor are two representatives of a new class of antineoplastic agents. In vitro studies have suggested synergistic cytotoxic activities when the agents are combined. We report a phase I study of these two agents when administered daily for 5 consecutive days every 2 weeks in patients with advanced gastrointestinal cancers. Toxicity resulting from these agents was significant with hyperbilirubinemia representing the dose-limiting toxicity. Significant, although transient, myelosuppression was also observed. The maximal tolerated doses were 150 µg/m²/day for 5 days for each agent. Suggestive antineoplastic activity in biliary and pancreatic cancer was observed. Phase II trials of this combination are currently in progress.

¹ To whom requests for reprints should be addressed.

Received 9/26/88. Revised 4/17/89. Accepted 4/20/89.

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