Phase II study of amonafide in patients with recurrent glioma.
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.
Levitt
R
R
St. Luke's Hospitals CCOP, Fargo, ND 58123, USA.
Buckner
J C
JC
Cascino
T L
TL
Burch
P A
PA
Morton
R F
RF
Westberg
M W
MW
Goldberg
R M
RM
Gallagher
J G
JG
O'Fallon
J R
JR
Scheithauer
B W
BW
D000225:Adenine; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001254:Astrocytoma / Q000188:drug therapy / Q000601:surgery; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D003131:Combined Modality Therapy; D005260:Female; D005910:Glioma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D006801:Humans; D007094:Imides / Q000009:adverse effects / Q000627:therapeutic use*; D007546:Isoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D053644:Naphthalimides; D009422:Nervous System Diseases / Q000139:chemically induced / Q000188:drug therapy; D009837:Oligodendroglioma / Q000188:drug therapy / Q000601:surgery; D063065:Organophosphonates; D012008:Recurrence; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D000970:Antineoplastic Agents; D007094:Imides; D007546:Isoquinolines; D053644:Naphthalimides; D063065:Organophosphonates; C037020:amonafide; D000225:Adenine