Overview
This is an open label study of apixaban for venous thromboembolism prevention in patients with newly diagnosed grade 4 glioma.
Description
Patients with primary brain tumors, including glioblastoma and astrocytoma, are at high risk of developing venous thromboemboli (VTE) as a comorbid condition. Prior studies have demonstrated safety and efficacy of primary pharmacological prevention of VTE using blood thinning medications, including apixaban. These studies have included a small cohort of patients with grade 4 glioma. The purpose of this study is to gather additional safety data regarding the use of apixaban for primary prevention of VTE in patients with newly diagnosed grade 4 glioma.
Eligibility
Inclusion Criteria:
- Histologic diagnosis of malignant glioma, World Health Organization (WHO) grade 4, including glioblastoma and astrocytoma, based on recent biopsy or resection.
- Age 18 and old
- Karnofsky performance status (KPS) 60-100
- Acceptable labs, including platelets of greater than or equal to 100,000, glomerular filtration rate (GFR) greater than or equal to 25.
- Ability to provide informed consent.
- Planning for treatment with radiation and chemotherapy.
Exclusion Criteria:
- Evidence of deep venous thrombosis (DVT), pulmonary embolism (PE), or cerebral vein thrombosis (CVT) within 6 months prior to enrollment on the study.
- Pregnancy.
- Significant bleeding risk including: history of symptomatic intracranial hemorrhage, active bleeding at time of study registration, clinically significant bleeding within 14 days of study registration, intracranial trauma in the past 6 months, including stroke or traumatic brain injury, major surgery or major procedure within 48 hours.
- Allergy to apixaban or contraindication to prophylactic anticoagulation. Contraindications include patients who are currently on unfractionated heparin, low molecular weight heparin, heparin derivatives (examples: fondaparinux), or other direct oral anticoagulants (examples: dabigatran, edoxaban, rivaroxaban), who are either unable or unable to discontinue these agents in favor of the investigational drug. Apixaban is also contraindicated in patients who are on strong CYP3A4 inhibitor and P-glycoprotein inhibitors.
- Indication for full anticoagulation (i.e. atrial fibrillation, mechanical valve, etc.).
- Estimated life expectancy of \<3 months.