Temozolomide and Ascorbic Acid in Treating Patients With Recurrent High-Grade Glioma
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|ClinicalTrials.gov Identifier: NCT02168270|
Recruitment Status : Terminated
First Posted : June 20, 2014
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma Glioblastoma Gliosarcoma||Dietary Supplement: ascorbic acid Drug: temozolomide Other: quality-of-life assessment Other: laboratory biomarker analysis||Phase 1|
I. To evaluate the toxicities and determine the recommended dose of intravenous ascorbic acid given three times weekly in combination with temozolomide 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 temozolomide.
II. Radiographic assessment of disease status after 2 cycles of therapy with ascorbic acid and temozolomide.
III. To evaluate progression-free and overall survival of patients with recurrent high grade glioma treated with therapy with ascorbic acid and temozolomide.
IV. To descriptively examine quality of life (QOL) using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (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 and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 2 months for 1 year and then periodically thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Metronomic Temozolomide and Intravenous Ascorbic Acid for Patients With Recurrent High Grade Glioma|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Experimental: Treatment (ascorbic acid, temozolomide)
Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Dietary Supplement: ascorbic acid
Other: quality-of-life assessment
Other Name: quality of life assessment
Other: laboratory biomarker analysis
- Maximum Tolerated Dose of Ascorbic Acid in Combination With Temozolomide, Defined as the Highest Dose Tested Which Results in Dose Limiting Toxicity (DLT) in no More Than One of Six Evaluable Patients [ Time Frame: 56 days ]Graded by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 4.0. DLT incidence will be described by dose level.
- Incidence Rates of Adverse Events, Graded According to the NCI Common Toxicity Criteria for Adverse Events Version 4.0 [ Time Frame: Up to 30 days after last administration of study medication ]The incidence rates of adverse events will be described by dose level. The frequency of occurrence of overall toxicity, categorized by toxicity grades, will be described.
- Changes in Serum Levels of Ascorbic Acid (Using HPLC With Coulometric Electrochemical Detection) [ Time Frame: Baseline to up to 52 weeks ]Correlation of intracellular glutathione (in peripheral blood mononuclear cells) with ascorbic acid levels during therapy with ascorbic acid and temozolomide will be summarized using descriptive statistics to summarize changes over time.
- Using Radiologic Measurements for Tumor Response [ Time Frame: Up to 52 weeks ]The measurement of effect will be based on the Macdonald criteria
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168270
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Nicole Shonka||University of Nebraska|