A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- GBM
- Glioblastoma
- Glioblastoma Multiforme
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT01752491
- Collaborators
- National Institutes of Health (NIH)
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: John M. Buatti, MD Department of Radiation Oncology, The University of Iowa Study Director: Joseph J Cullen, MD Professor of Surgery, The University of Iowa
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