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Phase II study of amonafide in patients with recurrent glioma
R Levitt1, J C Buckner, T L Cascino
1St. Luke's Hospitals CCOP, Fargo, ND 58123, USA.
Abstract:
Amonafide, a novel imide derivative with broad preclinical antitumor activity, achieves significant cerebrospinal fluid levels in animal models. In order to test its antitumor activity in patients with recurrent diffuse infiltrative glioma of the astrocytic and oligodendroglial type, we performed a phase II clinical trial. Of the 22 eligible and evaluable patients treated, 2 (9%) experienced tumor regression lasting more than one year. No other patients experienced tumor regression; one remained stable more than six months. Toxicities consisted primarily of myelosuppression, vomiting, and venous irritation at the infusion site. We conclude that amonafide has minimal activity in recurrent glioma patients. Further investigations are not warranted in this study population.
Insights
A novel anticancer drug, amonafide, showed minimal effectiveness in treating recurrent glioma patients in a phase II clinical trial. The drug demonstrated limited tumor regression and significant toxicities, suggesting further investigation is not recommended for this patient group.
Area of Science:
- Oncology
- Neuro-oncology
- Clinical Pharmacology
Background:
- Amonafide, an imide derivative, exhibits preclinical antitumor activity.
- It achieves notable cerebrospinal fluid penetration in animal models.
- Recurrent diffuse infiltrative glioma presents a therapeutic challenge.
Purpose of the Study:
- To evaluate the antitumor activity of amonafide in patients with recurrent diffuse infiltrative glioma.
- To assess the safety and tolerability of amonafide in this patient population.
Main Methods:
- A phase II clinical trial was conducted.
- Twenty-two eligible and evaluable patients with recurrent glioma received amonafide treatment.
- Tumor response and toxicities were monitored.
Main Results:
- Two out of 22 patients (9%) experienced tumor regression lasting over a year.
- One patient achieved stable disease for more than six months.
- Common toxicities included myelosuppression, vomiting, and infusion site venous irritation.
Conclusions:
- Amonafide demonstrated minimal clinical activity in patients with recurrent glioma.
- The observed toxicities were primarily hematological and gastrointestinal.
- Further investigation of amonafide in this specific patient population is not warranted based on these findings.