A phase II study of spirogermanium in advanced human malignancy

Area of Science:

• Oncology
• Pharmacology
• Toxicology

Background:

• Spirogermanium is a heavy metal compound featuring germanium within an azaspirane ring.
• Investigating novel therapeutic agents is crucial for advanced malignant neoplasms.

Purpose of the Study:

• To evaluate the toxicity and potential antitumor activity of spirogermanium in patients with advanced cancers.
• To determine an acceptable and effective dosage and administration schedule for spirogermanium.

Main Methods:

• A study involving 39 patients with advanced malignant neoplasms.
• Thirty-one patients were assessed for the toxic effects of spirogermanium.
• Evaluation of neurological, hematologic, renal, and hepatic toxicity, alongside antitumor responses.

Main Results:

• Transient neurological symptoms (dizziness, fatigue, visual blurring, ataxia, paresthesia, nausea) occurred in 39% of patients.
• Infusion over 2 hours, compared to 1 hour, reduced neurological symptoms.
• No significant hematologic, renal, or hepatic toxicity was observed; antitumor activity was not identified in heavily pretreated patients.

Conclusions:

• Spirogermanium demonstrated limited and acceptable toxicity at a dose of 120 mg/m2 infused over 2 hours, three times weekly.
• The observed neurological side effects were manageable, suggesting potential for further investigation with dose or schedule adjustments.