Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT00501891
Phase
PHASE2
Status
Completed

Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Bevacizumab administered intravenously 10mg/kg every other week.
  • Metronomic Temozolomide — DRUG
    Temozolomide 50mg/m2 given orally on a daily basis.

Study Details

This is a phase II study of the combination of Avastin and metronomic temozolomide in recurrent malignant glioma patients. The primary objective will be to determine the efficacy of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The secondary objective will be to determine the safety of Avastin, 10 mg/kg every other week, in combination with metronomic temozolomide in terms of progression-free survival.

Key Dates

First listed
Jul 16, 2007
Start date
Jul 31, 2007
Status verified
Mar 2013
Primary completion
Dec 31, 2007
Completion
Nov 30, 2009

Study Design

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

Arms

  • Experimental: Bevacizumab and Metronomic Temozolomide
    Patients will receive up to 12 cycles of bevacizumab (Avastin) and metronomic temozolomide (Temodar), and each cycle is 28 days. Bevacizumab will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.

Primary Outcome Measure

6-Month Progression-free Survival [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical Center (Brain Tumor Center)DurhamNorth Carolina27710-

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Duke University Medical Center (Brain Tumor Center)· Durham, NC

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