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Phase II evaluation of topotecan for pediatric central nervous system tumors.

Abstract：

BACKGROUND:Topotecan is a topoisomerase I inhibitor that has good penetration across the blood-brain barrier and significant antitumor activity against human brain tumor xenografts. In a Phase I trial in children with refractory cancer, topotecan was well tolerated when administered as a 24-hour infusion. The maximum tolerated dose was 5.5 mg/m2 and the dose-limiting toxicity was myelosuppression. This Phase II study of topotecan was performed to assess the activity of topotecan against childhood brain tumors. METHODS:Forty-five children with either a previously treated primary brain tumor that was refractory to standard therapy, or an untreated brain stem glioma or glioblastoma multiforme, received topotecan administered as a 24-hour intravenous infusion every 21 days. The initial dose was 5.5 mg/m2 with escalation to 7.5 mg/m2 on the second and subsequent doses in patients who did not experience dose-limiting toxicity. RESULTS:There were no complete or partial responses in the patients with high grade glioma (n=9), medulloblastoma (n=9), or brain stem glioma (n=14). One of 2 patients with a low grade glioma had a partial response lasting more than 17 months; 3 patients with a brain stem glioma had stable disease for 12 to 28 weeks; and 1 patient with a malignant neuroepithelial tumor and 1 patient with an optic glioma had stable disease for 41 weeks and 22 weeks, respectively. Dose escalation from 5.5 mg/m2 to 7.5 mg/m2 was well tolerated in the first 11 patients enrolled on this study who had not received prior craniospinal radiation therapy. The starting dose was subsequently increased to 7.5 mg/m2 for patients without prior craniospinal radiation. CONCLUSIONS:Topotecan administered as a 24-hour infusion every 21 days is inactive in high grade gliomas, medulloblastomas, and brain stem tumors.

journal_name

Cancer

journal_title

Cancer

authors

Blaney SM,Phillips PC,Packer RJ,Heideman RL,Berg SL,Adamson PC,Allen JC,Sallan SE,Jakacki RI,Lange BJ,Reaman GH,Horowitz ME,Poplack DG,Balis FM

doi

10.1002/(SICI)1097-0142(19960801)78:3<527::AID-CNC

subject

Has Abstract

pub_date

1996-08-01 00:00:00

pages

527-31

issue

eissn

0008-543X

issn

1097-0142

pii

10.1002/(SICI)1097-0142(19960801)78:3<527::AID-CNC

journal_volume

pub_type

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Phase II evaluation of topotecan for pediatric central nervous system tumors.