Phase 2 Study of High-Dose Vitamin C for Treating Glioblastoma Multiforme

Sponsor: Bryan Allen

Sponsor score: 0

ClinicalTrials ID:NCT02344355

Provider View

This clinical trial is testing whether adding high doses of vitamin C to the standard treatment for glioblastoma multiforme, a type of brain tumor, can improve outcomes for adult patients.

Patient Parameters

Program Overview

The study aims to find out if high doses of vitamin C, given through an IV, can enhance the effects of the usual treatment for glioblastoma multiforme, which includes surgery, radiation, and chemotherapy. All participants will receive the standard treatment along with the high-dose vitamin C.

Description

In this study, patients with glioblastoma multiforme will receive the standard treatment, which includes surgery to remove as much of the tumor as possible, followed by radiation and a chemotherapy pill called temozolomide. In addition to this, participants will receive high doses of vitamin C through an IV.

During the radiation and chemotherapy phase, patients will get vitamin C three times a week. After radiation, during the additional chemotherapy phase, they will receive vitamin C twice a week. This part of the study lasts for six months.

Participants will also complete quality of life and cognitive tests at various points: before radiation, during radiation, after radiation, and several months later. After the study treatment, patients will return to their regular cancer care and continue to be monitored for life as part of the study.

Eligibility Criteria

Inclusion Criteria

  • Must understand and agree to sign a consent form.
  • Newly diagnosed with glioblastoma multiforme within the last 5 weeks.
  • Diagnosis confirmed by a biopsy or surgery.
  • Treatment must start within 5 weeks after surgery or biopsy.
  • Age 18 or older.
  • Good overall health with a performance status score of 0 to 2.
  • Sufficient blood cell counts and organ function as determined by specific tests.
  • Able to tolerate a test dose of vitamin C.
  • Not pregnant.

Exclusion Criteria

  • Have a recurrent high-grade glioma.
  • Have a specific enzyme deficiency (G6PD deficiency).
  • Actively using insulin or checking blood sugar daily.
  • Allergic to temozolomide or similar drugs.
  • Have other serious brain diseases like multiple sclerosis.
  • Taking certain medications that cannot be changed.
  • Have another active cancer.
  • Have had previous chemotherapy or radiation for the current brain tumor.
  • Participating in another drug trial.
  • Have uncontrolled illnesses or conditions that could interfere with the study.
  • Pregnant or breastfeeding.
  • Known HIV-positive, as high-dose vitamin C can affect HIV medications.

Locations

FACILITYZIPCITYSTATE
Holden Comprehensive Cancer Center52242Iowa CityIowa

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