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A Phase 2 Trial of High-Dose Ascorbate in Glioblastoma Multiforme
Sponsor: Bryan Allen
Summary
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.
Official title: Pharmacological Ascorbate Combined With Radiation and Temozolomide in Glioblastoma Multiforme: A Phase 2 Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2017-03-13
Completion Date
2028-12
Last Updated
2025-12-12
Healthy Volunteers
No
Conditions
Interventions
Temozolomide
oral temozolomide (75 mg/m2), given 7 days per week, for a maximum of 49 days during radiation therapy. Starting 1 month after radiation therapy, additional temozolomide will be given as chemotherapy cycles. Each cycle is 28 days. For the first cycle, temozolomide will be administered (150 mg/m2) once per day for 5 days. If the subject tolerates the first cycle well, temozolomide will be prescribed at 200 mg/m2 for cycles 2 through 6. Each cycle is 28 days.
radiation therapy
Conformal radiation administered daily, M-F, to a total dose of 61.2 Gray in 34 fractions.
Ascorbic Acid
Intravenous infusions of 87.5g of ascorbate administered three times weekly during radiation. After radiation, ascorbate is administered twice weekly through the end of cycle 6 of temozolomide.
Locations (1)
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States