Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma

Conditions

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Recurrent Adult Brain Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• bevacizumab — BIOLOGICAL
  Staring within 14 days of randomization, IV 10mg/kg every two weeks until disease progression.
• radiation therapy — RADIATION
  Starting with second dose of bevacizumab, 35 Gy in 10 fractions of 3.5 Gy each delivered on consecutive treatment days (typically 5 fractions per week).

Study Details

This randomized phase II trial studies how well bevacizumab with or without radiation therapy works in treating patients with recurrent glioblastoma. 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 cancer-killing substances to them. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet know whether bevacizumab is more effective with or without radiation therapy in treating patients with recurrent glioblastoma

Key Dates

First listed

Nov 21, 2012

Start date

Dec 20, 2012

Status verified

Dec 2022

Primary completion

Sep 3, 2018

Completion

Dec 22, 2022

Study Design

Enrollment

182 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Bevacizumab
  Bevacizumab every 2 weeks
• Experimental: Bevacizumab + RT
  Radiation therapy with bevacizumab every 2 weeks

Primary Outcome Measure

Overall Survival [ Time Frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 52.8 months. ]

Locations (31)

Find similar trials in Birmingham, AL

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