Latest1 information on COVID-19
©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT03020602
A Phase I Study of BPM31510 Plus Vitamin K in Subjects With High-Grade Glioma That Has Recurred on a Bevacizumab Containing Regimen
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery
Clinical Associate Professor, Radiology
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery
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.
other: Laboratory Biomarker Analysis
other: Pharmacological Study
drug: Ubidecarenone Injectable Nanosuspension
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061