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

NCT03020602 | Completed Phase 1 DMC

• 3 other identifiers: IRB-38514NCI-2016-01973BRN0035
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gliosarcoma; Recurrent Glioblastoma; Astrocytoma of Brain; Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with dose-limiting toxicities defined as thrombocytopenia >= grade 3, hemorrhage >= grade 3, and INR elevation >= grade 2 assessed by CTCAE v4.03

  Will be tabulated at each dose, along with the result of the pooled adjacent violators algorithm as implemented in the Modified Toxicity Probability Interval (equal weights, and the weighted mean solver).

  Up to 28 days

Secondary Outcomes (1)

• Incidence of adverse events graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version (v)4.03

  Up to 30 days after last dose of BPM3150

Other Outcomes (4)

• Brain tumor metabolism as measured by PET

  Up to 8 weeks

• Overall survival (OS)

  From the date of BPM31510 initiation to death, assessed for up to 3 years

• PFS assessed by RANO criteria

  Up to 3 years

Study Arms (1)

Treatment (BPM31510)

EXPERIMENTAL

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.

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

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (BPM31510)

Pharmacological Study OTHER

Correlative studies

Treatment (BPM31510)

Ubidecarenone Injectable Nanosuspension DRUG

Given IV

Also known as: BP31510, Coenzyme Q10 Injectable Nanosuspension, Ubiquinone Injectable Nanosuspension

Treatment (BPM31510)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Seema Nagpal: lead

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Gliosarcoma; Glioblastoma

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Study Officials

• Seema Nagpal

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 13, 2017
• Study Start: January 4, 2017
• Primary Completion: April 4, 2019
• Study Completion: June 26, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)