Bevacizumab and Ascorbic Acid in Patients Treating With Recurrent High Grade Glioma
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|ClinicalTrials.gov Identifier: NCT02833701|
Recruitment Status : Terminated
First Posted : July 14, 2016
Last Update Posted : July 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Glioma||Dietary Supplement: Ascorbic Acid Biological: Bevacizumab Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Bevacizumab and Intravenous Ascorbic Acid for Patients With Recurrent High Grade Glioma|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||March 2019|
Experimental: Treatment (bevacizumab and ascorbic acid)
Patients receive ascorbic acid 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.
Dietary Supplement: Ascorbic Acid
Given intravenously (IV)
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
- Frequency of occurrence of overall toxicity [ Time Frame: Up to 52 weeks ]Categorized by toxicity grades.
- Incidence of dose limiting toxicities (DLT) [ Time Frame: Up to 56 days ]Described by dose level.
- Incidence rates of adverse events [ Time Frame: Up to 52 weeks ]Described by dose level.
- Maximum tolerated dose of ascorbic acid in combination with bevacizumab defined as the highest dose tested which results in DLT in no more than 1 of 6 evaluable patients [ Time Frame: Up to 56 days ]
- Changes in serum levels of ascorbic acid using HPLC with coulometric electrochemical detection [ Time Frame: Week 1 to up to Week 52 ]Correlation of intracellular glutathione with ascorbic acid levels during therapy with ascorbic acid and temozolomide will be summarized using descriptive statistics to summarize changes over time.
- Disease status by radiologic assessment [ Time Frame: Up to 56 days ]Disease status measured by radiologic assessment.
- Progression free survival [ Time Frame: First date of therapy until the first notation of clinical progression, relapse or death from any cause, assessed up to 1 year ]Will be plotted following the method of Kaplan and Meier.
- QOL using EORTC QLQ-C30 [ Time Frame: Up to 52 weeks ]Will be descriptively summarized using means and standard deviations.
- Survival [ Time Frame: First date of therapy until the date of death from any cause, assessed up to 1 year ]Will be plotted following the method of Kaplan and Meier.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833701
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Nicole Shonka||University of Nebraska|