Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma

NCT00501891 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-05-27

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Bevacizumab

Bevacizumab administered intravenously 10mg/kg every other week.

DRUG

Metronomic Temozolomide

Temozolomide 50mg/m2 given orally on a daily basis.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY
  • Schering-Plough

    collaborator INDUSTRY
  • Duke University

    lead OTHER

Principal Investigators

  • Annick Desjardins, MD · Duke Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2007-12-31
Completion
2009-11-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00501891 on ClinicalTrials.gov