Leading pharmaceutical companies drug development pipelines are yielding more sophisticated candidate therapies for patients diagnosed with a primary brain tumor, this according to researchers at UCLA Medical Center. Genentech’s latest drug, Avastin is one of the most promising drugs introduced by the pharmaceutical giant. Bevacizumab, or Avastin is a monoclonal antibody that binds to the vascular endothelial growth factor (VEGF) protein and is looking to help slow the growth of these fast moving tumors.
“Numerous publications have indicated VEGF to be been found secreted in the tissue of Glioblastoma Multiforme tumors, mediate tumor angiogenesis and ultimately lead to progression of disease,“ explains Dr. Albert Lai of the UCLA Neuro-Oncology Program. “Avastin attempts to prevent this process by binding to vascular endothelial growth factor protein and impeding angiogenesis. “
Avastin has already been approved by the Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer, and preliminary studies have shown that the relatively new drug may be able to increase treatment response rate ten fold.
In response to this new data UCLA Neuro-Oncology is sponsoring a Phase II trial which will further evaluate the safety and effectiveness of Avastin when taken alone or when taken in combination with Irinotecan a topoisomerase inhibitor. Irinotecan is also an FDA-approved drug for the treatment of certain other cancers that directly attacks and damages cancer cells. The study will also determine whether Avastin with or without Irinotecan can prevent or slow the growth of the tumor and lead to increase length of survival.
The treatment cycle for the study involves Radiation Therapy for six weeks with daily Temozolomide administered orally from days 1 to 42. Upon completion of Radiation Therapy, Temozolomide with be continued at monthly cycles of 5 days on, 23 days off. Avastin is given through an intravenously infusion every two weeks beginning on the first day of Radiation Therapy, and then continued for two years.
Enrollment is limited to 70 patients. All patients must have been newly-diagnosed with Glioblastoma Multiforme primary brain tumor. Patients must NOT have received any prior radiation therapy or chemotherapy.
According the UCLA Neuro-Oncology program 10 patients have already been enrolled thus far. “Avastin is not only the newest drug in our arsenal, but is also showing promising results when used in a combination therapy setting,” explains Dr. Timothy Cloughesy Program Director of the UCLA Neuro-Oncology.
Unique to the UCLA sponsored study is the requirement fresh tissue must be collected for enrollment in the study. This critical component will allow UCLA researchers to determine whether the presence of genetic alterations, gene expression and promoter methylation patterns can predict whether this drug is effective on the tumor when taken with conventional treatment.
Surgery may be performed at any institution; however tissue must be saved according to the study protocol guidelines and transported to UCLA Medical Center under “fresh-frozen” conditions.
For more information on this clinical trial opportunity, please call Emese Filka, Clinical Trials Coordinator of the UCLA Neuro-Oncology Program, at (310) 794-3521.
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