Bevacizumab in Recurrent Grade II and III Glioma

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT01164189
Phase
PHASE2
Status
Completed

Conditions

  • Central Nervous System Tumors

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    Bevacizumab (vial of 400mg/16mL) at a dose of 10 mg/kg bodyweight i.v. in 90 min on day 1 and day 14 of 4 week cycles
  • Temozolomide — DRUG
    Temozolomide (250, 100, 20 and 5 mg caps) will be administered orally on day 1-5, 150-200 mg/m², and will be repeated every 4 weeks. This will be repeated for up to 12 cycles.

Study Details

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide is more effective when given with or without bevacizumab in treating patients with recurrent glioma. PURPOSE: This randomized clinical trial is studying how well temozolomide works with or without bevacizumab in treating patients with recurrent glioma.

Key Dates

First listed
Jul 16, 2010
Start date
Feb 28, 2011
Status verified
Feb 2019
Primary completion
Jan 19, 2017
Completion
Sep 24, 2017

Study Design

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

Arms

  • Other: Temozolomide
    Administered orally on day 1-5, 150-200 mg/m(2), repeated every 4 weeks, up to 12 cycles
  • Experimental: Temozolomide + Bevacizumab
    TMZ: Administered orally on day 1-5, 150-200 mg/m(2), repeated every 4 weeks, up to 12 cycles Beva: 10 mg/kg bw IV in 90 minutes on day 1 and 14, 4 week cycles.

Primary Outcome Measure

Probability of survival at 1 year [ Time Frame: From the date of randomization up to the date of death, assessed up to 12 months ]

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