Webster Marc, Cairncross Gregory, Gertler Stan, Perry James, Wainman Nancy, Eisenhauer Elizabeth
Tom Baker Cancer Centre, Calgary, Alberta, Canada.
Invest New Drugs. 2005 Dec;23(6):591-6. doi: 10.1007/s10637-005-1761-3.
A multi-centre phase II study of SarCNU-a novel chloroethylnitrosourea (CNU)-in patients with recurrent malignant glioma to assess response rate, survival and effects of treatment.
Ten patients with histologically proven malignant glioma (seven with glioblastoma multiforme (GBM) and three with anaplastic astrocytoma) received SarCNU (860 mg/m(2)) orally on days 1, 5 and 9 on a 6 week schedule.
A total of ten patients were treated on protocol before accrual was suspended for a high rate of pulmonary toxicity. Of eight evaluable patients, five demonstrated at least one grade deterioration in DLCO from baseline. This necessitated premature closure of the trial. Stable disease was seen in five of seven evaluable patients (median duration 4.8 months; range 0.8-9.2) with progressive disease in the remainder.
Despite promising preclinical data, SarCNU caused pulmonary toxicity in patients with recurrent malignant glioma and we plan no further studies in this indication.
一项关于SarCNU（一种新型氯乙基亚硝脲（CNU））用于复发性恶性胶质瘤患者的多中心II期研究，以评估缓解率、生存率及治疗效果。
10例经组织学证实为恶性胶质瘤的患者（7例多形性胶质母细胞瘤（GBM）和3例间变性星形细胞瘤）按照6周的疗程，在第1、5和9天口服SarCNU（860mg/m²）。
在因肺部毒性发生率高而暂停入组前，共有10例患者按方案接受了治疗。在8例可评估的患者中，5例患者的一氧化碳弥散量（DLCO）较基线水平至少下降了1级。这使得试验不得不提前终止。7例可评估患者中有5例病情稳定（中位持续时间4.8个月；范围0.8 - 9.2个月），其余患者病情进展。
尽管临床前数据很有前景，但SarCNU在复发性恶性胶质瘤患者中引起了肺部毒性，我们计划不再针对该适应症开展进一步研究。
