caa a22 4500 465789277 CHVBK 20180323112018.0 cr unu---uuuuu 170327e19900201xx s 000 0 eng 10.1007/BF00216924 doi (NATIONALLICENCE)springer-10.1007/BF00216924 Phase I study of oral spirogermanium [Elektronische Daten] [Jimmie Harvey, Molly McFadden, Frederick Smith, Lucien Joubert, Philip Schein] Summary: Thirty-three patients with advanced malignancy were treated with oral spirogermanium in a Phase I study to determine a maximum tolerated dose. Patients were entered in the study at doses of 100, 200, and 300 milligrams daily. The dose-limiting toxicity was gastrointestinal with moderate nausea and vomiting occurring with the 300 milligram dose. No myelosuppression or renal dysfunction was noted. Elevations of serum transaminase were seen in 41 percent of the patients at study entry. While abnormalities in hepatic function were recorded during the study, the relationship to spirogermanium could not be determined. No patient exhibited clinical hepatic dysfunction or elevation of serum bilirubin. It is recommended that future studies of oral spirogermanium incorporate careful monitoring of these parameters. Two patients with lymphoproliferative disorders had objective responses to therapy. A dose of 200 milligrams is recommended for further Phase II trials. Kluwer Academic Publishers, 1990 spirogermanium nationallicence phase I nationallicence oral nationallicence Harvey Jimmie Vincent T. Lombardi Cancer Research Center, Georgetown University School of Medicine, Washington D.C., USA aut McFadden Molly Vincent T. Lombardi Cancer Research Center, Georgetown University School of Medicine, Washington D.C., USA aut Smith Frederick Vincent T. Lombardi Cancer Research Center, Georgetown University School of Medicine, Washington D.C., USA aut Joubert Lucien Unimed, Inc., 35 Columbia Road, 08876-3587, Somerville, NJ, USA aut Schein Philip Vincent T. Lombardi Cancer Research Center, Georgetown University School of Medicine, Washington D.C., USA aut Investigational New Drugs Kluwer Academic Publishers 8/1(1990-02-01), 53-56 0167-6997 8:1<53 1990 8 10637 https://doi.org/10.1007/BF00216924 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/BF00216924 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Harvey Jimmie Vincent T. Lombardi Cancer Research Center, Georgetown University School of Medicine, Washington D.C., USA aut NATIONALLICENCE 700 1- McFadden Molly Vincent T. Lombardi Cancer Research Center, Georgetown University School of Medicine, Washington D.C., USA aut NATIONALLICENCE 700 1- Smith Frederick Vincent T. Lombardi Cancer Research Center, Georgetown University School of Medicine, Washington D.C., USA aut NATIONALLICENCE 700 1- Joubert Lucien Unimed, Inc., 35 Columbia Road, 08876-3587, Somerville, NJ, USA aut NATIONALLICENCE 700 1- Schein Philip Vincent T. Lombardi Cancer Research Center, Georgetown University School of Medicine, Washington D.C., USA aut NATIONALLICENCE 773 0- Investigational New Drugs Kluwer Academic Publishers 8/1(1990-02-01), 53-56 0167-6997 8:1<53 1990 8 10637 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer