Seeking Adults with Recurrent High Grade Gliomas


16463

Phase I/Comparative Randomized Phase II Trial of TRC105 plus Bevacizumab Versus Bevacizumab in Bevacizumab-Naïve Patients with Recurrent Glioblastoma Multiform (N1174)

Neurology

Schiff David,

Seeking Adults with Recurrent High Grade Gliomas UVA Health System seeks men and women, 18 and older, with recurrent Grade 3 or Grade 4 gliomas, to participate in a clinical research study. High grade gliomas are brain tumors that include glioblastomas, anaplastic astrocytomas, anaplastic oligodendrogliomas and anaplastic oligoastrocytomas. Initial treatment for these tumors often combines surgery, radiation therapy and chemotherapy. The radiation therapy is in the form of external beam radiation administered over approximately 6 weeks. Temozolomide (Temodar), an oral medication, is the standard chemotherapy drug used, and is taken at the same time you undergo radiation therapy. Unfortunately, even with optimal therapy, high grade gliomas are essentially incurable. When these types of tumors recur, antiangiogenic agents such as bevacizumab (Avastin) have shown some encouraging results; however, tumors eventually develop resistance to bevacizumab.. The purpose of this study is to determine how well the investigational drug, TRC105, controls tumor growth after recurrence. Patients who have tumor progression as evidenced by CT scan or MRI are eligible, as are patients who have undergone gross total resection of the tumor. Patients who have been treated with bevacizumab (Avastin) and other chemotherapy agents are eligible. TRC-105 is an investigational agent in this study – it is not approved by the FDA for the treatment of high-grade gliomas. If you agree to participate and your doctor determines you are eligible to enroll, you will be treated with the investigational drug TRC-105 and standard of care bevacizumab (Avastin). TRC-105 is given to you intravenously once per week. Bevacizumab (Avastin) is given to you intravenously every 2 weeks. You will continue to receive the study drugs as long as you do not experience tumor growth (as documented by MRI) and/or experience unacceptable drug effects. Participants in this study will have routine neurological and physical exams performed as well as tumor evaluations done by MRI. Blood and urine samples will be collected for routine, or standard of care, testing. Additional blood will be collected at certain times for specific research tests required by 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: Monika Thielen Phone: (434)-243-9900 Email: mjt3c@Virginia.edu Primary Investigator: David Schiff, MD IRB-HSR# 16463


Adult

Brain Cancer
Brain Tumor
Gliomas

Neurosurgery
Neurology
Neuro-Oncology
Cancer (Oncology)

Ill

No Compensation

Monica Thielen

mjt3c@virginia.edu

4342439900