Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent Glioblastoma Multiforme

Conditions

• Adult Anaplastic Astrocytoma
• Adult Anaplastic Oligodendroglioma
• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Adult Mixed Glioma
• Recurrent Adult Brain Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Anti-Endoglin Chimeric Monoclonal Antibody TRC105 — BIOLOGICAL
  Given IV
• Bevacizumab — BIOLOGICAL
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Pharmacological Study — OTHER
  Correlative studies
• Quality-of-Life Assessment — OTHER
  Ancillary studies

Study Details

This partially randomized phase I/II trial studies the side effects and the best dose of anti-endoglin monoclonal antibody TRC105 when given together with bevacizumab and to see how well they work in treating patients with glioblastoma multiforme that has come back. Monoclonal antibodies, such as anti-endoglin monoclonal antibody TRC105 and bevacizumab, may find tumor cells and help kill them. Giving anti-endoglin monoclonal antibody TRC105 together with bevacizumab may be an effective treatment for glioblastoma multiforme.

Key Dates

First listed

Jul 24, 2012

Start date

Nov 30, 2012

Status verified

Apr 2018

Primary completion

May 11, 2016

Completion

Apr 15, 2017

Study Design

Enrollment

116 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (bevacizumab and TRC105)
  Patients receive bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
• Active Comparator: Arm II (bevacizumab)
  Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) (Phase I) as Measured by the Number of Participants With Dose Limiting Toxicities [ Time Frame: 28 days ]

Locations (308)

Find similar trials in Little Rock, AR

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