Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme

Conditions

• Brain and Central Nervous System Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• bevacizumab — BIOLOGICAL
• sorafenib tosylate — DRUG

Study Details

RATIONALE: 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. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with sorafenib may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab together with sorafenib works in treating patients with recurrent glioblastoma multiforme.

Key Dates

First listed

Feb 22, 2008

Start date

Sep 30, 2008

Status verified

Apr 2018

Primary completion

Oct 31, 2010

Completion

Feb 19, 2014

Study Design

Enrollment

54 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Sorafenib + Bevacizumab/Group A
  Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days. Patients undergo blood and plasma sample collection at baseline and then periodically during study treatment for translational research studies. Translational research studies include analysis of circulating endothelial cells and circulating endothelial progenitor cells by flow cytometry and measurement of angiogenic proteins in plasma by ELISA. DNA and buffy coat are extracted and collected from the blood samples for pharmacogenetic studies. Quality of life is assessed at baseline, prior to every other treatment course, and at the end of treatment. After completion of study treatment, patients are followed at 28-42 days, every 3 months for 5 years, and then annually for 10 years.
• Experimental: Sorafenib + Bevacizumab /Group B
  Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days. Patients undergo blood and plasma sample collection at baseline and then periodically during study treatment for translational research studies. Translational research studies include analysis of circulating endothelial cells and circulating endothelial progenitor cells by flow cytometry and measurement of angiogenic proteins in plasma by ELISA. DNA and buffy coat are extracted and collected from the blood samples for pharmacogenetic studies. Quality of life is assessed at baseline, prior to every other treatment course, and at the end of treatment. After completion of study treatment, patients are followed at 28-42 days, every 3 months for 5 years, and then annually for 10 years.

Primary Outcome Measure

6-month Progression-free Survival [ Time Frame: at 6 months ]

Locations (204)

Find similar trials in Scottsdale, AZ

Related Studies

• 3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
  Recruiting · Barbara Ann Karmanos Cancer Institute · Detroit, Michigan
• Novel Indenoisoquinolone CMYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma
  PHASE1/PHASE2 · Recruiting · National Institute of Neurological Disorders and Stroke (NINDS) · Bethesda, Maryland