Bevacizumab and Temozolomide Following Radiation and Chemotherapy for Newly Diagnosed Glioblastoma Multiforme
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
This study is being conducted to help determine whether the addition of Avastin (an
anti-cancer drug), when given along with temozolomide during the monthly cycles that follow
radiation, is able to delay tumor growth, shrink tumors, or impact how long people with GBM
live. This study is sponsored by Genentech, Inc., the manufacturer of Avastin.
Avastin is the experimental drug being administered in this research study. Avastin binds a
protein called vascular endothelial growth factor, or VEGF. VEGF is produced by tumors and
circulates in the blood. One of VEGF's main roles is to support the growth of new blood
vessels. During cancer, VEGF promotes the growth of blood vessels that bring nutrients to
tumor cells and help them grow. Avastin binds to VEGF, which then prevents VEGF from
functioning. In laboratory studies, Avastin prevented the growth of several different types
of cancer cells grown in animals. Avastin was approved by the Food and Drug Administration
(FDA) for the treatment of metastatic colorectal cancer in combination with chemotherapy.
Avastin has not been approved by the FDA for the treatment of GBM and is, therefore,
considered experimental. Avastin is currently undergoing testing (alone and in combination
with another anti-cancer drug, irinotecan) in persons with GBM that have come back after
conventional treatment.
Temozolomide (Temodar) is an anti-cancer drug that works by interfering with the growth of
cells (including cancer cells) by stopping their division. Temozolomide was approved by the
U.S. FDA for the treatment of newly diagnosed GBM in 2005.
Avastin and temozolomide are currently being used together in several research studies
involving people with newly diagnosed GBM. Limited information is available about either the
safety or effectiveness of this drug combination.