NCT01752491

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Joseph J. Cullen, MD, FACS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma
• GBM
• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Ascorbate	Intravenous infusion of high-dose ascorbate
DRUG	Temozolomide	Oral chemotherapeutic
RADIATION	Radiation therapy	External beam radiation therapy

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-11-30
• Completion: 2019-11-15
• First posted: 2012-12-19
• Last updated: 2024-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study