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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

March 13, 2017

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
Glioblastoma Multiforme
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."

Trial Locations (1)

52242

Holden Comprehensive Cancer Center, Iowa City

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Holden Comprehensive Cancer Center

OTHER

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Gateway for Cancer Research

OTHER

lead

Bryan Allen

OTHER