This phase II trial studies how well high-dose ascorbic acid, temozolomide, and radiation therapy work in treating patients with glioblastoma. Dietary supplements, such as ascorbic acid, may improve the tolerability of chemotherapy regimens. 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving high-dose ascorbic acid, temozolomide, and radiation therapy may work better in treating patients with glioblastoma.
Additional locations may be listed on ClinicalTrials.gov for NCT02344355.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Determine the overall survival of patients with newly diagnosed glioblastoma multiforme (GBM) treated with high dose ascorbic acid (ascorbate) and standard radiation combined with chemotherapy.
SECONDARY OBJECTIVES:
I. Determine the progression free survival of patients with newly diagnosed GBM treated with high dose ascorbate and standard radiation combined with chemotherapy.
II. Determine tumor response using the criteria defined by MacDonald et al.
III. Categorize and quantify adverse events in GBM subjects when treated with the combination of temozolomide, radiation and high-dose ascorbic acid compared to temozolomide and radiation alone.
TERTIARY OBJECTIVES:
I. Determine health-related quality of life outcomes (HRQOL) using the validated European Organization for Research and Treatment of Cancer (EORTC) questionnaires quality of life questionnaire (QLQ)- core (C)30 and BN-20.
II. Compare health-related quality of life outcomes to the findings of Stupp et al in the pivotal EORTC study defining concomitant therapy for GBM.
OUTLINE:
Patients undergo radiation therapy 5 days per week. Patients also receive temozolomide orally (PO) once daily (QD) and ascorbic acid intravenously (IV) over 150 minutes 3 times per week during radiation therapy.
POST-RADIATION THERAPY: Patients receive ascorbic acid IV over 150 minutes twice weekly.
ADJUVANT THERAPY: Patients receive temozolomide PO QD on days 1-5 and ascorbic acid IV over 150 minutes twice weekly for 4 weeks for a total of 8 infusions. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months.
Lead OrganizationUniversity of Iowa/Holden Comprehensive Cancer Center
Principal InvestigatorBryan G. Allen
