Phase I study of oral spirogermanium

Abstract

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.

Hydrogeochemical and biomedical insights into germanium potential of curative waters: a case study of health resorts in the Sudetes Mountains (Poland)

“…Tanaka et al 1984 ; Nagahama et al 1986 ; Nakata et al 1986 ; Aso et al 1988 ; Goodman 1988b ; Konno et al 1990 ; Hirono et al 1991 ; Fujii et al 1993 ; Seaborn and Nielsen 1994 ; Hirayama et al 2003 ). Phase I and phase II trials of spirogermanium as a therapy for cancer have been performed (Dhingra et al 1986 ; Harvey et al 1990 ). The molecular mechanism involved in beneficial applications of germanium could be explained by its preventive effect on the inhibition of gap junctional intercellular communication (Kang et al 2001 ), which is an important event during the promotional stage of cancer.…”