NCT02833701

Bevacizumab and Ascorbic Acid in Patients Treating With Recurrent High Grade Glioma

A Phase I Study of Bevacizumab and Intravenous Ascorbic Acid for Patients With Recurrent High Grade Glioma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of ascorbic acid when given together with bevacizumab in treating patients with high grade glioma that has come back (recurrent). Monoclonal antibodies, such as bevacizumab may interfere with the ability of tumor cells to grow and spread. Ascorbic acid contains ingredients that may prevent or slow the growth of high grade glioma. Giving bevacizumab and ascorbic acid together may work better in treating patients with high grade glioma.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the toxicities and determine the recommended dose of intravenous ascorbic acid given three times weekly in combination with intravenous bevacizumab every two weeks in patients with recurrent high grade glioma. SECONDARY OBJECTIVES: I. To evaluate changes in the levels of serum ascorbic acid (using high performance liquid chromatography \[HPLC\] with coulometric electrochemical detection) during therapy with ascorbic acid and bevacizumab. II. Radiographic assessment of disease status after 2 cycles of therapy with ascorbic acid and bevacizumab. III. To evaluate progression-free and overall survival of patients with recurrent high grade glioma treated with therapy with ascorbic acid and bevacizumab. Patients with stable or responsive disease after every 2 cycles will continue on therapy with ascorbic acid and bevacizumab until intolerance or progressive disease. IV. To descriptively examine quality of life (QOL) using European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire QLQ-C30 during treatment. OUTLINE: This is a dose-escalation study of ascorbic acid. Patients receive ascorbic acid intravenously (IV) over 90-120 minutes three times per week (at least 24 hours apart) and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months for 1 year.

Conditions

• Glioblastoma
• Glioma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ascorbic Acid	Given IV
BIOLOGICAL	Bevacizumab	Given intravenously (IV)
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2016-07-14
• Last updated: 2023-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study