title: Phase I study of the cisplatin analogue 1,1-diamminomethylcyclohexane sulfatoplatinum (TNO-6) (NSC 311056).
abstract: The cisplatin derivative TNO-6 was evaluated for clinical toxicity in a phase I trial. TNO-6 was given daily for 5 days every 3 weeks as a 30-min IV infusion without hydration. In all, 39 patients with advanced cancer were treated at doses of 2.5-9.0 mg/m2. No dose-limiting nephrotoxicity occurred, but evidence of mild, reversible tubular damage was found. Dose-limiting toxicity was hematologic with both thrombopenia and leukocytopenia, which with high dose levels reached WHO grade 4. Hematologic toxicity was most pronounced for pretreated patients. No antitumor activity was seen. The recommended dose for phase II trials will be 9.0 mg/m2 for previously untreated and 8.0 mg/m2 for pretreated patients.
mesh_terms: D000328:Adult; D000368:Aged; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007465:Iodohippuric Acid; D007684:Kidney Tubules / Q000000981:diagnostic imaging / Q000187:drug effects / Q000473:pathology; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009369:Neoplasms / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects*; D004369:Pentetic Acid; D011507:Proteinuria / Q000139:chemically induced; D011877:Radionuclide Imaging; D013667:Technetium; D016284:Technetium Tc 99m Pentetate; D013921:Thrombocytopenia / Q000139:chemically induced
chemical_list: D009944:Organoplatinum Compounds; D007465:Iodohippuric Acid; D013667:Technetium; D004369:Pentetic Acid; C040757:spiroplatin; D016284:Technetium Tc 99m Pentetate