A Phase 2 Trial of High-Dose Ascorbate in Glioblastoma Multiforme

• Status: Active, not recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial evaluates adding high-dose ascorbate (vitamin C) to standard of care treatment of glioblastoma multiforme (a type of brain tumor) in adults. All subjects will receive high-dose ascorbate in addition to the standard treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bryan Allen; University of Iowa
• Collaborators: Holden Comprehensive Cancer Center; National Cancer Institute (NCI)
• Treatments: Ascorbic Acid; Dacarbazine; Temozolomide

Criteria

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.