Suberoylanilide Hydroxamic Acid (SAHA), Bevacizumab, Daily Temozolomide for Recurrent Malignant Gliomas

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Katy Peters
Study ID
NCT00939991
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorinostst/Bevacizumab/Temozolomide — DRUG
    Bevacizumab will be administered intravenously at the dose 10 mg/kg every other week. Temozolomide will be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat will be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat will be escalated in successive cohorts of patients to determine the MTD of this regimen. Bevacizumab doses may be given by the local oncologists under the direction of the Duke investigators.

Study Details

This is a Phase I/II open-label, single-arm study among recurrent malignant glioma patients. Patients will be treated with Vorinostat in combination with Bevacizumab (BV) (10 mg/kg) and Temozolomide (T) (50 mg/m2/day) BV is administered every 2 weeks. Temozolomide will be taken orally once every day. Vorinostat will be taken orally on days 1-7 and 15-21 of each 28-day cycle. In the phase I portion of this study, the dose of Vorinostat will be escalated in successive cohorts of patients to determine the maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs). In the phase II portion of this study, the dose of Vorinostat will be the MTD determined in the phase I portion. The primary endpoint of the phase II study is 6-month progression-free survival (PFS) for recurrent GBM (Glioblastoma) patients. This study will be conducted at The Preston Robert Tisch Brain Tumor Center at Duke.

Key Dates

First listed
Jul 15, 2009
Start date
Oct 31, 2009
Status verified
May 2013
Primary completion
Jan 31, 2012
Completion
Apr 30, 2013

Study Design

Enrollment
48 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Phase I- Bevacizumab will be administered intravenously every other week. Temozolomide will be administered on a continuous daily dosing schedule. Vorinostat will be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat will be escalated in successive cohorts of patients to determine the MTD of this regimen.

Primary Outcome Measure

Phase I: Determination of the Maximum Tolerated Dose (MTD) [ Time Frame: Cycle 1 (28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Duke University Medical Center· Durham, NC

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