Seeking Adults with Recurrent Glioblastoma Multiforme


16660

Phase II Study of AMG 386 with and without Bevacizumab for Recurrent Glioblastoma

Neurology

Schiff David,

UVA Health System seeks men and women, 18 and older, with recurrent Glioblastoma Multiforme (also referred to as glioblastoma or GBM) to participate in a clinical research study. Patients who have either grade III or grade IV high-grade gliomas are eligible to participate in this study. GBM is a type of glioma arising from glial cells. It is relatively rare, with an incidence of roughly 2 or 3 cases per 100,000 people. Brain tumors can be classified as slow growing or low grade (grade I or II) or high grade and fast growing (grade III or IV). Glioblastoma is classified as a high grade or aggressive tumor and there is currently no effective form of curative treatment for this disease. The standard treatment for GBM combines surgery, radiation therapy and chemotherapy. The radiation therapy is in the form of external beam radiation. Temozolomide is the standard chemotherapy drug used. Unfortunately, even with optimal therapy, GBM is essentially incurable. When these types of tumors recur, other agents are sometimes of modest benefit. Patients in this trial must not have received prior treatment that included bevacizumab (Avastin). The purpose of this portion of the study is to determine what dose of the investigational drug, AMG 386, works the best with bevacizumab to control tumor growth after tumor recurrence. AMG 386 is the investigational agent in this study – it is not approved by the FDA for the treatment of high-grade gliomas. Should you agree to participate and your doctor determines you are eligible to enroll; you will be treated with the investigational drug called AMG 386 and Avastin. AMG 386 will be infused intravenously once a week during each treatment cycle. Avastin is also given via infusion and will be given biweekly during each treatment cycle. Each treatment cycle is 28 days in length. You will continue to receive the study drug as long as you do not experience tumor growth as documented by magnetic resonance imaging (MRI) or have unacceptable drug effects. You may also choose to stop treatment at any time. Participants in this study will have routine medical and physical exams performed as well as tumor evaluations done by MRI. Blood work will also be collected for routine testing (which is called standard of care) as well as research tests required for the study. You will not receive payment for participating in this study. For more information or to see if you qualify to take part in this study, please contact: Contact: Heather Tribout Clinical Research coordinator Neuro-Oncology Phone: (434)-243-9360 Email: mjt3c@virginia.edu Primary Investigator: David Schiff, MD Accepts adult enrollment: Yes IRB-HSR# 16660 – Cohort B PhI


Adult

Brain Cancer
Brain Tumor
Glioblastoma

Neurosurgery
Neuro-Oncology
Cancer (Oncology)

Ill

No Compensation

Heather Tribout

hjt3f@virginia.edu

4342439360