Glioblastoma Clinical Trial
Official title:
A Phase I Trial of Vorinostat in Combination With Bevacizumab and Irinotecan in Recurrent Glioblastoma
The purpose of the this study is to see if an investigations cancer treatment called vorinostat can be combined with the irinotecan/bevacizumab regimen safely.
Drug Administration: (A cycle is 28 days) Irinotecan and bevacizumab are given IV on days 1
and 15 of each cycle. Vorinostat is given orally on days 1-7 and 15-21 of each cycle.
Vorinostat (provided in 100mg capsules) begins at a dose of 200mg/day, escalating to
300mg/day and then to a maximum of 400mg/day. Vorinostat will be taken prior to irinotecan
and bevacizumab on days 1 and 15. The drug should be administered at the same time every day
for days 2-7 and 16-21. Patients will be treated prophylactically with compazine 30 minutes
prior to vorinostat which, in turn, should be taken 30 minutes prior to a meal whenever
possible.
Irinotecan is given at a dose of 125mg/m². Bevacizumab is given at a dose of 10mg/kg.
Maximum tolerated dose (MTD) will be defined by toxicities occurring during the first 4
weeks of therapy. Three patients will be treated at dose level one and can be enrolled
simultaneously. They must be observed for dose limiting toxicities (DLT) for at least 4
weeks from treatment day 1. Page 15 of the protocol outlines the dose escalation parameters.
At least 9 patients will be treated at the MTD. If DLT is not achieved in any cohort of up
to a dose level of 400mg/day of vorinostat, further dose escalations will not be made. This
dose will then become the recommended dose.
Patients demonstrating evidence of benefit may be treated up to a maximum of 24 cycles, at
the investigator's discretion.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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