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Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01752491
Study type Interventional
Source University of Iowa
Contact
Status Active, not recruiting
Phase Phase 1
Start date April 1, 2013
Completion date December 31, 2024

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