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ACTIVE NOT RECRUITING
NCT02344355
PHASE2

A Phase 2 Trial of High-Dose Ascorbate in Glioblastoma Multiforme

Sponsor: Bryan Allen

View on ClinicalTrials.gov

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

Interventions

DRUG

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

radiation therapy

Conformal radiation administered daily, M-F, to a total dose of 61.2 Gray in 34 fractions.

DRUG

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