A Phase 2 Trial of High-Dose Ascorbate in Glioblastoma Multiforme
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Glioblastoma Multiforme
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention 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
Standard treatment for glioblastoma multiforme (GBM) involves maximum safe surgical resection followed by radiation combined with temozolomide (a chemotherapy pill you take by mouth). After radiation, patients receive additional cycles of temozolomide (adjuvant chemotherapy). Participants will: rece...
Standard treatment for glioblastoma multiforme (GBM) involves maximum safe surgical resection followed by radiation combined with temozolomide (a chemotherapy pill you take by mouth). After radiation, patients receive additional cycles of temozolomide (adjuvant chemotherapy). Participants will: receive high doses of intravenous (IV) ascorbate three times a week during the combined radiation and chemotherapy phase receive high doses of intravenous (IV) ascorbate twice a week during adjuvant chemotherapy (after radiation) complete health-related quality of life questionnaires pre-radiation, 4 weeks into radiation, 4 weeks after radiation, and then every 3 months. In addition, patients will complete neurocognitive testing pre-radiation, 4 weeks into radiation, 4 weeks after radiation, and approximately 9 months after initiating radiation therapy. The adjuvant chemotherapy portion of this study lasts for 6 months. After that is completed, participants will go back to standard therapy for their cancer. Participants will continue to have life-long follow-up for this study.
Tracking Information
- NCT #
- NCT02344355
- Collaborators
- Holden Comprehensive Cancer Center
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Bryan G. Allen, MD, PhD Assistant Professor, Department of Radiation Oncology, The University of Iowa