Related Experiment Videos
Phase I trial of teroxirone
Cancer Treatment Reports
|September 1, 1984
Summary
Teroxirone, a novel alkylating agent, showed preclinical anticancer activity. Clinical trials revealed severe local toxicities, suggesting further animal studies are needed before repeated human administration.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Teroxirone is a novel triepoxide alkylating agent.
- It exhibits broad-spectrum preclinical cytotoxic activity, including against cyclophosphamide-resistant leukemias.
Purpose of the Study:
- To evaluate the safety and tolerability of teroxirone in cancer patients.
- To determine the maximal tolerated dose (MTD) for further clinical investigation.
Main Methods:
- Thirty-six patients received teroxirone intravenously for 5 consecutive days every 4 weeks.
- Dose-limiting toxicities and MTD were assessed.
Main Results:
- The MTD was determined to be 340 mg/m²/day x 5.
- Dose-limiting toxic effects included severe phlebitis and cutaneous flare reactions.
- Nausea, vomiting, and myelosuppression occurred but were not dose-limiting at the MTD.
Conclusions:
- Teroxirone demonstrates significant local toxicities that may preclude repeated administration without a central line.
- Further animal studies are warranted to assess the safety of repeated administration via a central line before initiating Phase II human trials.