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.

• Authors: J Harvey, M McFadden, F P Smith, L Joubert, P S Schein
• Journal: Investigational new drugs (Invest New Drugs) Vol. 8 Issue 1 Pg. 53-6 (Feb 1990) ISSN: 0167-6997 [Print] United States
• PMID: 2345069 (Publication Type: Journal Article)

Chemical References

• Antineoplastic Agents
• Organometallic Compounds
• Spiro Compounds
• spirogermanium

Topics

• Administration, Oral
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
• Dose-Response Relationship, Drug
• Drug Evaluation
• Female
• Humans
• Liver Function Tests
• Male
• Middle Aged
• Organometallic Compounds (administration & dosage, adverse effects, therapeutic use)
• Spiro Compounds (administration & dosage, adverse effects, therapeutic use)