BPM31510 in Treating Patients With Recurrent High-Grade Glioma Previously Treated With Bevacizumab

This is an interventional treatment trial for Gliosarcoma Read More

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.