A Phase I Trial of Vorinostat in Combination With Bevacizumab & Irinotecan in Recurrent Glioblastoma
Part of paid clinical trials in Tampa, Florida.
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Study ID
- NCT00762255
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Vorinostat — DRUGVorinostat, Bevacizumab and Irinotecan Study. Determine maximum tolerated dose for treatment.
- Bevacizumab — DRUGVorinostat, Bevacizumab and Irinotecan Study. Determine maximum tolerated dose for treatment.
- Irinotecan — DRUGVorinostat, Bevacizumab and Irinotecan Study. Determine maximum tolerated dose for treatment.
Study Details
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.
Key Dates
- Start date
- Sep 30, 2008
- Status verified
- Jul 2013
- Primary completion
- Jul 31, 2013
- Completion
- Jul 31, 2013
Study Design
- Enrollment
- 19 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: A - Phase I Dose EscalationDose Escalation - 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.
- Experimental: B - Treatment at Maximum Tolerated Dose (MTD)MTD - Treatment at maximum tolerated dose
Primary Outcome Measure
Maximum Tolerated Dose (MTD) [ Time Frame: 25 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| H. Lee Moffitt Cancer Center & Research Institute, Inc. | Tampa | Florida | 33612 | - |
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