Seeking Adults with Recurrent High-Grade Glioma Tumors


17288

A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients with Recurrent High-Grade Glioma

Neurology

Schiff David,

UVA Health System seeks men and women, 18 and older, with recurrent High-Grade Glioma to participate in a clinical research study. Gliomas are a type of tumor arising from glial cells of the brain or spinal cord. Gliomas can be classified as slow growing or low grade (grade I or II) or high grade and fast growing (grade III or IV). Glioblastoma Multiforme (GBM) is the most common tumor classified as a high-grade glioma. This study will include patients with high-grade gliomas that recur after initial treatment. The standard treatment for high-grade gliomas 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 (such as bevacizumab which is approved for this use) are sometimes of modest benefit. Patients in this trial may have received prior chemotherapy, including bevacizumab (Avastin). If you have already received Avastin, your physician may decide with you to continue treatment with Avastin while you participate in this trial. The purpose of this study is to measure the tumor response rate and progression-free survival of patients treated with ANG1005. ANG1005 an investigational agent which means it is not yet 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 ANG1005. ANG1005 will be infused intravenously once each three week treatment cycle. 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 be collected at various points during the cycle for routine testing (which is called standard of care). Additional blood samples for research only will be collected at the start of each cycle. Patients may also opt to donate tumor samples as part of the study. Participants will receive $50 compensation for the clinic visit associated with each cycle start (day 1). The infusion visits are long so they will take place the day after the clinic visit. Therefore, participants who live more than 3 hours away will be given an additional $100 compensation for each day 1 visit. 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: hjt3f@virginia.edu Primary Investigator: David Schiff, MD Accepts adult enrollment: Yes IRB-HSR# 17288


Adult

Brain Tumor
Gliomas

Neurosurgery
Neuro-Oncology
Cancer (Oncology)

Ill

Compensation may be available. Refer to study description for details

Heather Tribout

hjt3f@virginia.edu

4342439360