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Phase I study of tricyclic nucleoside phosphate
Cancer Treatment Reports
|February 1, 1983
Summary
This phase I trial investigated tricyclic nucleoside phosphate in advanced cancer patients. High doses caused liver damage and hyperglycemia, suggesting limited therapeutic potential with this dosing regimen.
Area of Science:
- Oncology
- Pharmacology
- Hepatology
Background:
- Advanced cancer presents significant treatment challenges.
- Novel therapeutic agents are continuously explored for improved patient outcomes.
Purpose of the Study:
- To evaluate the safety and tolerability of tricyclic nucleoside phosphate in adults with advanced cancer.
- To determine the maximum tolerated dose (MTD) and dose-limiting toxicities of tricyclic nucleoside phosphate.
Main Methods:
- A phase I clinical trial was conducted with 20 adult patients.
- Tricyclic nucleoside phosphate was administered intravenously every 3 weeks.
- Dose escalation ranged from 25 to 350 mg/m2.
Main Results:
- Hyperglycemia and elevated hepatocellular enzymes were observed starting at 250 mg/m2.
- Irreversible liver damage occurred in two patients at the highest dose (350 mg/m2).
- Serum phosphorus reduction occurred at all doses; serum calcium reduction was dose-dependent.
Conclusions:
- Tricyclic nucleoside phosphate demonstrated significant dose-limiting toxicities, particularly hepatotoxicity.
- The observed toxicities and lack of major therapeutic responses suggest this dosing schedule is not warranted for further clinical trials.