This phase II trial studies how well bavituximab with radiation therapy and temozolomide work in treating patients with glioblastoma. Immunotherapy with monoclonal antibodies, such as bavituximab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bavituximab, temozolomide with radiation therapy may kill more tumor cells and work better in treating glioblastoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03139916.
PRIMARY OBJECTIVES:
I. To determine the proportion of patients alive at 12 months (OS12).
SECONDARY OBJECTIVES:
I. Progression free survival.
II. Toxicity of bavituximab in this patient population.
OUTLINE:
CHEMORADIATION: Patients undergo radiation therapy on days 1-5 over 1-3 hours, then receive bavituximab intravenously (IV) over 60-90 minutes once a week, and temozolomide orally (PO) once daily (QD) on days 1-42. Treatment repeats 6 weeks for up to 1 course in the absence of disease progression or unacceptable toxicity.
POST RADIATION: Patients receive bavituximab IV over 60-90 minutes once a week, then beginning course 3, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 4 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients may continue beyond 18 weeks at the discretion of the treating physician if the patient is deriving clinical benefit.
After completion of study treatment, patients are followed up every 3 months for 5 years.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorElizabeth R. Gerstner
