Spots Global Cancer Trial Database for A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme

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Trial Identification

Brief Title: A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme

Official Title: A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme

Study ID: NCT01752491

Conditions

Glioblastoma

GBM

Glioblastoma Multiforme

Interventions

Ascorbate

Temozolomide

Radiation therapy

Study Description

Brief Summary: This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate (vitamin C) to standard radiation and chemotherapy for initial treatment of glioblastoma multiforme (GBM).

Detailed Description: This phase 1 study will test the safety of adding high dose ascorbate (vitamin C) to standard chemoradiation and, after the radiation is completed, during 6 cycles of temozolomide. Standard treatment for glioblastoma multiforme (GBM) involves surgery followed by radiation combined with temozolomide (a chemotherapy). After radiation, patients receive cycles of temozolomide (adjuvant chemotherapy) Participants will: * receive high doses of intravenous (IV) ascorbate three times a week during chemoradiation * receive high doses of intravenous (IV) ascorbate twice a week during adjuvant chemotherapy (after radiation) This is a phase 1 study will evaluate the side effects of adding this drug to the standard therapy. The dose given to a participant will be determined by how well other participants have tolerated the drug.