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Investigational New Drugs 2006-May

Pre-irradiation 9-amino [20s] camptothecin (9-AC) in patients with newly diagnosed glioblastoma multiforme.

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Daniel Farray
Manmeet S Ahluwalia
Josette Snyder
Gene H Barnett
Bruce H Cohen
John H Suh
David M Peereboom

Keywords

Abstract

OBJECTIVE

To evaluate the efficacy of 9-amino [20s] camptothecin (9-AC) given before radiation therapy to patients with newly diagnosed glioblastoma multiforme (GBM).

METHODS

Eligible patients had newly diagnosed GBM who had residual measurable contrast-enhancing tumor. The trial was a phase 2 trial of 9-AC at 1100 microg/m2 /24 h infused over 72 h every two weeks for up to six cycles in patients with newly diagnosed GBM before radiation therapy.

RESULTS

Fourteen patients entered the study and all were evaluable. All of the patients had progressive disease by imaging criteria after at least two cycles of 9-AC (1 month). The median overall survival was 7.5 months (range 1.5-18 months). The most common adverse event was transient lymphopenia (grade 3-4). One patient developed grade 4 neutropenic fever that resolved after three days of diagnosis.

CONCLUSIONS

9-AC lacks activity against glioblastoma multiforme (GBM). Further studies looking at the efficacy of 9-AC in GBM may be futile.

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