Purpose: 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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