General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04752813

Background Information

The purpose of this research study is to see if the study drug, BPM31510 and Vitamin K1 are effective in treating and slowing down the progression of GB, when combined with standard radiation therapy and temozolomide. The researchers want to find out what effects (good and bad) BPM31510 has on you and your condition.

Offered At

Inova Schar Cancer Institute 
8081 Innovation Park Drive
Fairfax, VA 22031
Principal Investigator

Adam Cohen, MD

Eligibility Information

  • Subjects with newly diagnosed pathologically verified GB with any evidence of residual disease (enhancing or fast fluid-attenuated inversion-recovery [FLAIR]).
  • No prior RT, chemotherapy, immunotherapy, or targeted agents administered specifically for the lesion being treated.
  • Age ≥18 years old.
  • Karnofsky performance score ≥60.
  • Be at least 14 days out from surgery.

Ineligibility Information

  • History of clinically significant tumor-related cerebral hemorrhage.
  • Any of the following cardiac history:
    • Active heart disease including myocardial infarction within previous 3 months
    • Symptomatic coronary artery disease
    • Clinically significant arrhythmias not controlled by medication
    • Unstable angina pectoris
    • Uncontrolled or symptomatic congestive heart failure (New York Heart Association Class III and IV)
  • 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:
    • Severe epistaxis
    • Hemoptysis
    • Hematochezia
    • Hematuria
    • GI bleeding
    • Spontaneous or tumor-related intracranial hemorrhage
  • Known predisposition for bleeding such as von Willebrand's disease or other such condition(s).
  • Uncontrolled infection.
  • 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 y prior to first dose of study drug.
  • Receiving any of the following medications:
    • Therapeutic doses of any anticoagulant. Concomitant use of warfarin, even at prophylactic doses, is prohibited.
    • Digoxin, digitoxin, lanatoside C, or any type of digitalis alkaloids.
    • Antiangiogenic drugs (i.e., Avastin) either in the past 2 weeks or if anticipated within the next 2 weeks of informed consent.
    • Theophylline
  • Known allergy to CoQ10.
  • Known allergy or adverse reaction to oral, subcutaneous, or IV Vitamin K1.
  • Known to be positive for the human immunodeficiency virus (HIV).
  • Subjects with a contraindication to radiation.