Clinical Trial Finder

Inclusion Criteria:

• - Be ≥ 18 years of age.

• - Have a life expectancy ≥ 6 weeks.

• - Have a Karnofsky Performance Score (KPS) ≥ 60.

• - Have pathologically proven GB, gliosarcoma (WHO IV), or anaplastic astrocytoma (WHO III) in recurrence after treatment with bevacizumab.

• - Be at least 14 days from the last administration of bevacizumab.

• - Be at least 28 days from last administration of cytotoxic chemotherapy or other investigational agent.

• - Have received radiation therapy with concurrent temozolomide.

Total radiation dosage can range from 5400 to 6000 cGy administered in daily fractions of 150 to 200 cGy over 6 weeks, or the equivalent in a hypofractionated protocol (for example, 4000cGy in 15 fractions or 2500cGy in 5 fractions). Patients who are MGMT negative do not need to have received temozolomide.

• - Have adequate organ and marrow function as follows (all required): - ANC ≥ 1500 mm3.

• - Platelets ≥ 100,000/mm3.

• - Hemoglobin ≥ 9 g/dL.

• - Serum creatinine ≤ 1.8 mg/dL or creatinine clearance > 50 mL/min Bilirubin ≤ 1.5 mg/dL.

• - Alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) - Aspartate transaminase (AST) ≤ 2.5 x ULN.

• - Prothrombin time (PT) ≤ 1.5 x ULN.

• - International Normalized Ratio (INR) ≤ 1.5 x ULN.

• - Partial thromboplastin time (PTT) ≤ 1.5 x ULN.

• - Subjects of childbearing potential must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study.

• - Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• - Has a history of spontaneous or tumor related cerebral hemorrhage; or has cerebral hemorrhage as determined by the screening FDG PET CT and MRI.

This does not include stable post operative blood products seen on a gradient echo MRI sequence.

• - Has the any of the following cardiac history: - Active heart disease including myocardial infarction within previous 3 months.

• - Symptomatic coronary artery disease.

• - Arrhythmias not controlled by medication.

• - Unstable angina pectoris.

• - Uncontrolled or symptomatic congestive heart failure (NYHA class III and IV) 3.2.

3 Uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months, including any of the following, but not limited to:

• - Epistaxis.

• - Hemoptysis.

• - Hematochezia.

• - Hematuria.

• - Gastrointestinal bleeding.

• - Spontaneous or tumor related intracranial hemorrhage.

• - Known predisposition for bleeding such as von Willebrand's disease or other such condition(s) - Uncontrolled concurrent illness that would limit compliance with study requirements, including any of the following, but limited to: - Uncontrolled infection.

• - Psychiatric illness/social situations.

• - Prior malignancy except for non melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 years prior to 1st dose of investigational drug.

• - Receiving any of the following medications: - Therapeutic doses of any anticoagulant, including low molecular weight heparin (LMWH).

Concomitant use of warfarin, even at prophylactic doses, is prohibited.

• - Digoxin, digitoxin, lanatoside C, or any type of digitalis alkaloids.

• - Colony stimulating factors (CSFs) that cannot be held during the monitoring period for dose limiting toxicities (DLT) - Has significant toxicities from prior treatment that have not resolved or stabilized.

• - Known allergy to Coenzyme Q10.

• - Known allergy or adverse reaction to oral, subcutaneous, or intravenous vitamin K.

• - Is pregnant or lactating.

• - Known to be positive for the human immunodeficiency virus (HIV).

Note: HIV testing is not required for eligibility, but if performed previously and was positive, the subject is ineligible.

Primary Objective:

• - Assess the safety and tolerability of BPM31510 plus vitamin K in subjects with high-grade glioma(HGG), defined as anaplastic astrocytoma (AA) or glioblastoma (GB) that has recurred on a BEV containing regimen.

Secondary Objectives:

• - To evaluate plasma pharmacokinetics (PK) when BPM31510 plus vitamin K is given to subjects with HGG recurrent on a BEV containing regimen.

Exploratory Objectives:

• - Estimate the overall survival in subjects with HGG recurrent on a BEV containing regimen from the 1st day of infusion of BPM31510 plus vitamin K to death.

• - To evaluate the effects of BPM31510 plus vitamin K on shifting HGG metabolism to aerobic respiration by PET imaging.

• - To evaluate the effects of BPM1510 plus vitamin K on MRI imaging by Response Assessment in Neuro Oncology (RANO) criteria [specifically progression free survival (PFS) and response rate (RR)].

• - To evaluate plasma pharmacodynamics (PD) when BPM31510 plus vitamin K is given to subjects with HGG recurrent on a BEV containing regimen.

Arms

Experimental: Treatment (BPM31510)

Patients receive ubidecarenone injectable nanosuspension IV over 72 hours twice weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Interventions

Other: - Laboratory Biomarker Analysis

Correlative studies

Other: - Pharmacological Study

Correlative studies

Drug: - Ubidecarenone Injectable Nanosuspension

Given IV