Clinical Trial RTOG 1122
- Phase II Double-Blinded Placebo-Controlled Study of Bevacizumab with or without AMG 386 in Patients with Recurrent Glioblastoma or Gliosarcoma
- Principal Investigator
- Jeffrey Raizer
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.RTOG 1122
- The purpose of this study is to find out if adding a new investigational drug, AMG 386 to bevacizumab is has a greater effect than bevacizamb alone.
- Glioblastoma (GBM) is the most common and aggressive malignant primary brain tumor of adults. Standard therapy for newly diagnosed GBM patients involves surgery, followed by radiotherapy combined with adjuvant temozolomide (TMZ). TMZ plus radiation therapy has increased survival in patients, but after first progression, response to chemotherapy is rare. The demand for better therapies is high. Angiogenesis, the growth of new blood vessels to tumors, is a prominent feature of GBM. Bevacizumab is a vascular endothelial growth factor (VEGF) inhibitor, meaning it inhibits the growth of blood vessels. While bevacizumab is active in treating GBM, eventually resistance to the drug develops. Resistance may be due to redundancy of angiogenesis stimulators, including Ang1 and Ang2, which are both protein growth factors. AMG 386 is a new investigational drug that stops Ang1 and Ang2 from interacting with cells that contribute to tumor growth.
Some of the eligibility criteria include:
- Participants must have glioblastoma that has gotten worse after prior therapy.
- Participants must be 18 years of age or older.
- Description of Treatment
- This study is broken into two parts (Cohort 1 and Cohort 2). Those subjects who are eligible and consent to participate will be enrolled in Cohort 1 or 2, depending on how far along the study is in enrollment. Cohort 1 will test the safety of the combination of AMG 386, given weekly, and bevacizumab, given every 2 weeks, in participants who have never received any anti-VEGF treatment. Participants in Cohort 2 will be randomly assigned to one of two groups (a control and experimental arm). In the control arm study subjects will receive bevacizumab every 2 weeks plus a placebo weekly, until disease progression or significant toxicity develops. In the experimental arm subjects will get bevacizumab every 2 weeks plus a AMG 386 weekly, until disease progression or significant toxicity develops. Participants who progress and are determined at unblinding to have received bevacizumab alone will be allowed to cross over and receive treatment with open-label AMG 386.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 01-Aug-14 10:52 AM
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