Phase i trial of recombinant human gamma-interferon and recombinant human tumor necrosis factor in patients with advanced gastrointestinal cancer
Abbruzzese, J.L.; Levin, B.; Ajani, J.A.; Faintuch, J.S.; Saks, S.; Patt, Y.Z.; Edwards, C.; Ende, K.; Gutterman, J.U.
Cancer Research 49(14): 4057-4061
1989
ISSN/ISBN: 0008-5472 PMID: 2500234 Document Number: 339417
Recombinant human gamma-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 micrograms/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.