title: Phase I trial of recombinant human gamma-interferon and recombinant human tumor necrosis factor in patients with advanced gastrointestinal cancer.
abstract: 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.
authors.affiliation: Department of Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston 77030.
authors.forename: J L
authors.initials: JL
authors.lastname: Abbruzzese
authors.forename: B
authors.initials: B
authors.lastname: Levin
authors.forename: J A
authors.initials: JA
authors.lastname: Ajani
authors.forename: J S
authors.initials: JS
authors.lastname: Faintuch
authors.forename: S
authors.initials: S
authors.lastname: Saks
authors.forename: Y Z
authors.initials: YZ
authors.lastname: Patt
authors.forename: C
authors.initials: C
authors.lastname: Edwards
authors.forename: K
authors.initials: K
authors.lastname: Ende
authors.forename: J U
authors.initials: JU
authors.lastname: Gutterman
mesh_terms: D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D005260:Female; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy / Q000628:therapy*; D006801:Humans; D007371:Interferon-gamma / Q000009:adverse effects / Q000627:therapeutic use*; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D013921:Thrombocytopenia / Q000139:chemically induced; D014409:Tumor Necrosis Factor-alpha / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D011994:Recombinant Proteins; D014409:Tumor Necrosis Factor-alpha; D007371:Interferon-gamma