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Phase II trial of amonafide in central nervous system tumors: a Southwest Oncology Group study
Sarah A Taylor1, Cathryn Rankin, Jeannette J Townsend
1University of Kansas Medical Center, Kansas City, USA.
Abstract:
Amonafide 300 mg/M2 was administered intravenously on a daily x 5 schedule to 27 eligible patients with recurrent or progressive central nervous system tumors. There were no objective responses. The most common toxicities were gastrointestinal, hematologic and neurologic. Further study of amonafide in patients with central nervous system malignancies is not indicated.
Insights
Amonafide showed no effectiveness in treating recurrent central nervous system tumors. The drug caused significant gastrointestinal, hematologic, and neurologic toxicities, indicating it is not suitable for further study in these patients.
Area of Science:
- Oncology
- Pharmacology
- Neuro-oncology
Background:
- Central nervous system (CNS) tumors are a significant challenge in oncology.
- Recurrent or progressive CNS malignancies often have limited treatment options.
- Novel therapeutic agents are continuously investigated for CNS malignancies.
Purpose of the Study:
- To evaluate the efficacy and safety of amonafide in patients with recurrent or progressive CNS tumors.
- To determine the objective response rate of amonafide in this patient population.
- To identify the common toxicities associated with amonafide treatment.
Main Methods:
- A phase II clinical trial was conducted.
- Twenty-seven eligible patients with recurrent or progressive CNS tumors were enrolled.
- Amonafide was administered intravenously at a dose of 300 mg/M2 daily for 5 days.
Main Results:
- No objective responses were observed in any of the patients treated.
- The most frequent toxicities included gastrointestinal, hematologic, and neurologic adverse events.
- The study did not meet its primary endpoint of demonstrating efficacy.
Conclusions:
- Amonafide did not demonstrate efficacy in patients with recurrent or progressive CNS tumors.
- The observed toxicities suggest a poor therapeutic index for amonafide in this setting.
- Further investigation of amonafide for CNS malignancies is not recommended.
