Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma

Part of paid clinical trials in Dallas, Texas.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01266031
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • vorinostat — DRUG
    Vorinostat 400mg/day will be administered on day 1 to 7 and day 15 to 21 orally on a 28 day cycle in the arm with combination of vorinostat and bevacizumab. Vorinostat will be administered orally. Vorinostat capsules should not be opened or crushed and must be administered whole.
  • bevacizumab — DRUG
    Bevacizumab 10mg/kg will be administered on day 1 and 15 intravenously on a 28 day cycle in both arms.

Study Details

The goal of this Phase I portion of this clinical research study is to find the highest tolerable dose of bevacizumab with or without vorinostat, that can be given to patients with malignant gliomas. The safety of these drug combinations will also be studied. The goal of this Phase II part of this clinical research study is to learn if bevacizumab when given with or without vorinostat can help to control malignant gliomas. The safety of these drug combinations will also be studied.

Key Dates

Start date
Jul 12, 2011
Status verified
Jul 2018
Primary completion
Jun 30, 2015
Completion
Jan 31, 2017

Study Design

Enrollment
96 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab
    10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.
  • Experimental: Vorinostat and Bevacizumab
    Vorinostat: 400 mg/day by mouth on days 1 to 7 and days 15 to 21 of a 28 day cycle. Bevacizumab: 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.

Primary Outcome Measure

Progression Free Survival (PFS) at 6 Months [ Time Frame: Baseline until disease progression or death due to any cause, up to six months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor University Medical CenterDallasTexas75246-

Find similar trials in Dallas, TX

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Baylor University Medical Center· Dallas, TX

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