A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of grade 3, 4, & 5 adverse events
Assess grade 3 and higher adverse events. Evaluate the frequency and severity against the published literature to determine the likely causality between ascorbate and the adverse event(s).
Weekly during therapy for up to 10 months
Yes
John M. Buatti, MD
Principal Investigator
Department of Radiation Oncology, The University of Iowa
United States: Food and Drug Administration
201211713
NCT01752491
April 2013
March 2016
Name | Location |
---|---|
Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |