NCT00762255

A Phase I Trial of Vorinostat in Combination With Bevacizumab & Irinotecan in Recurrent Glioblastoma

A Phase I Trial of Vorinostat in Combination With Bevacizumab and Irinotecan in Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Vorinostat	Vorinostat, Bevacizumab and Irinotecan Study. Determine maximum tolerated dose for treatment.
DRUG	Bevacizumab	Vorinostat, Bevacizumab and Irinotecan Study. Determine maximum tolerated dose for treatment.
DRUG	Irinotecan	Vorinostat, Bevacizumab and Irinotecan Study. Determine maximum tolerated dose for treatment.

Timeline

• Start date: 2008-09-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2008-09-30
• Last updated: 2013-07-25

Locations

1 site across 1 country: United States