Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT01738646
Phase
PHASE2
Status
Completed

Conditions

  • Adult Brain Tumor
  • Malignant Glioma
  • Recurrent Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

It has been shown that bevacizumab has significant anti-tumor activity in patients with recurrent glioblastoma multiforme. Vorinostat has modest anti-tumor activity against malignant glioma and can enhance the action of both chemotherapy and anti-angiogenics. Patients will be treated with a combination of bevacizumab and vorinostat.

Key Dates

Start date
Jan 31, 2013
Status verified
Nov 2016
Primary completion
Dec 31, 2014
Completion
Feb 29, 2016

Study Design

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

Arms

  • Experimental: Vorinostat & Bevacizumab
    Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.

Primary Outcome Measure

Six-month Progression-free Survival (PFS6) [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Cancer CenterDurhamNorth Carolina27710-

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