Phase II evaluation of topotecan for pediatric central nervous system tumors.
In: Cancer, Jg. 78 (1996-08-01), Heft 3, S. 527-31
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Zugriff:
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.
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Phase II evaluation of topotecan for pediatric central nervous system tumors.
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Autor/in / Beteiligte Person: | 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 |
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Zeitschrift: | Cancer, Jg. 78 (1996-08-01), Heft 3, S. 527-31 |
Veröffentlichung: | <2005- >: Hoboken, NJ : Wiley ; <i>Original Publication</i>: New York [etc.] Published for the American Cancer Society by J. Wiley [etc.], 1996 |
Medientyp: | academicJournal |
ISSN: | 0008-543X (print) |
DOI: | 10.1002/(SICI)1097-0142(19960801)78:3<527::AID-CNCR21>3.0.CO;2-# |
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