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Temozolomide and Ascorbic Acid in Treating Patients With Recurrent High-Grade Glioma

Glioblastoma Clinical Trial

Official title:
A Phase I Study of Metronomic Temozolomide and Intravenous Ascorbic Acid for Patients With Recurrent High Grade Glioma

Clinical Trial Summary

This phase I trial studies the side effects and best dose of ascorbic acid when given together with temozolomide in treating patients with high-grade glioma that has come back. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ascorbic acid contains ingredients that may prevent or slow the growth of high-grade gliomas. Giving temozolomide with ascorbic acid may kill more tumor cells.

Clinical Trial Description

PRIMARY OBJECTIVES: 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. 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 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02168270
Study type Interventional
Source University of Nebraska
Contact
Status Terminated
Phase Phase 1
Start date June 16, 2014
Completion date August 20, 2015
View Details
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