Bevacizumab With or Without Trebananib in Treating Patients With Recurrent Brain Tumors

Conditions

• Giant Cell Glioblastoma
• Glioblastoma
• Gliosarcoma
• Oligodendroglioma
• Recurrent Brain Neoplasm
• Recurrent Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Pharmacological Study — OTHER
  Correlative studies
• Placebo Administration — OTHER
  Given IV
• Trebananib — BIOLOGICAL
  Given IV

Study Details

This partially randomized phase II trial with a safety run-in component studies the side effects and how well bevacizumab given with or without trebananib works in treating patients with brain tumors that have come back (recurrent). Immunotherapy with monoclonal antibodies, such as bevacizumab, may induce changes in the body's immune system and interfere with the ability of tumor cells to grow and spread. Trebananib may stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving bevacizumab together with trebananib is more effective than bevacizumab alone in treating brain tumors.

Key Dates

First listed

Jun 1, 2012

Start date

Jun 4, 2012

Status verified

May 2022

Primary completion

Oct 2, 2015

Completion

May 20, 2022

Study Design

Enrollment

137 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (bevacizumab and trebananib)
  Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Active Comparator: Arm II (bevacizumab and placebo)
  Patients receive bevacizumab as in Arm I and placebo IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm I.

Primary Outcome Measure

Number of Patients Experiencing of Dose-limiting Toxicity (Cohort 1) [ Time Frame: From start of treatment to 4 weeks. ]

Locations (243)

Find similar trials in Anchorage, AK

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