Could High-Dose vitamin c boost brain cancer treatment?
NCT ID NCT02344355
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding high-dose vitamin C to the usual treatment (radiation and chemotherapy) helps adults with a newly diagnosed aggressive brain tumor called glioblastoma. About 90 participants will receive the vitamin C infusions alongside standard care. The goal is to see if this combination can help people live longer and keep the tumor from growing.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2017
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ability to understand and willingness to sign informed consent (power of attorney and/or legally authorized representatives cannot sign on behalf of the patient) * Patients must have newly diagnosed (i.e., within 5 weeks), histologically or cytologically confirmed glioblastoma multiforme. * Diagnosis must be made by surgical biopsy or excision. * Therapy must begin ≤ 5 weeks after surgery or biopsy * Age ≥ 18 years * ECOG performance status 0-2. (KPS \> 50) * Absolute neutrophil count (ANC) ≥ 1500 cells per mm3 * Platelets ≥ 100,000 per mm3 * Hemoglobin ≥ 8 g/dL * Creatinine ≤ 2.0 mg * Total bilirubin ≤ 1.5 mg/dL * ALT ≤ 3 times the institutional upper limit of normal * AST ≤ 3 times the institutional upper limit of normal * Tolerate one test dose (15g) of ascorbate. * Not pregnant. Exclusion Criteria: * Recurrent high grade glioma * G6PD (glucose-6-phosphate dehydrogenase) deficiency. * Patients actively receiving insulin or using a finger-stick glucometer daily for blood glucose measurements * History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide. * Significant co-morbid central nervous system disease, including but not limited to, multiple sclerosis. * Patients who are on the following drugs and cannot have a drug substitution: warfarin, flecainide, methadone, amphetamines, quinidine, and chlorpropamide. * Known active concurrent malignancy, as determined by treating physicians. * Patients who have received prior chemotherapy (including Gliadel wafers) for the current glioma. * Prior radiation therapy to the head or neck resulting in overlap of RT fields. * Patients receiving any other investigational agents (imaging agents are acceptable) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection that would result in a hospital stay or delay of treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or impact patient safety. * Pregnant women. * Breastfeeding women. * Known HIV-positive individuals. High-dose ascorbate acid is a known CYP450 3A4 inducer, which results in lower serum levels of antiretroviral drugs.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
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