Trial Search Results

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

This phase I trial studies the side effects and best dose of ubidecarenone injectable nanosuspension (BPM31510) in treating patients with high-grade glioma (anaplastic astrocytoma or glioblastoma) that has come back and have been previously treated with bevacizumab. BPM31510 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Seema Nagpal

Stanford Investigator(s):

Intervention(s):

  • Other: Laboratory Biomarker Analysis
  • Other: Pharmacological Study
  • Drug: Ubidecarenone Injectable Nanosuspension

Phase:

Phase 1

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sophie Bertrand
650-723-4467
Recruiting