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Pharmacological Ascorbate Combined With Radiation and Temozolomide in Glioblastoma Multiforme: A Phase 2 Trial
This clinical trial evaluates adding high-dose ascorbate (vitamin C) to standard of care treatment of glioblastoma multiforme (a type of brain tumor) in adults. All subjects will receive high-dose ascorbate in addition to the standard treatment.
Standard treatment for glioblastoma multiforme (GBM) involves maximum safe surgical resection followed by radiation combined with temozolomide (a chemotherapy pill you take by mouth). After radiation, patients receive additional cycles of temozolomide (adjuvant chemotherapy). Participants will: * receive high doses of intravenous (IV) ascorbate three times a week during the combined radiation and chemotherapy phase * receive high doses of intravenous (IV) ascorbate twice a week during adjuvant chemotherapy (after radiation) * complete health-related quality of life questionnaires pre-radiation, 4 weeks into radiation, 4 weeks after radiation, and then every 3 months. In addition, patients will complete neurocognitive testing pre-radiation, 4 weeks into radiation, 4 weeks after radiation, and approximately 9 months after initiating radiation therapy. The adjuvant chemotherapy portion of this study lasts for 6 months. After that is completed, participants will go back to standard therapy for their cancer. Participants will continue to have life-long follow-up for this study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Start Date
March 13, 2017
Primary Completion Date
December 31, 2026
Completion Date
December 1, 2028
Last Updated
December 12, 2025
90
ESTIMATED participants
Temozolomide
DRUG
radiation therapy
RADIATION
Ascorbic Acid
DRUG
Lead Sponsor
Bryan Allen
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07100730