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

NCT02344355 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-12-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Temozolomide

oral temozolomide (75 mg/m2), given 7 days per week, for a maximum of 49 days during radiation therapy. Starting 1 month after radiation therapy, additional temozolomide will be given as chemotherapy cycles. Each cycle is 28 days. For the first cycle, temozolomide will be administered (150 mg/m2) once per day for 5 days. If the subject tolerates the first cycle well, temozolomide will be prescribed at 200 mg/m2 for cycles 2 through 6. Each cycle is 28 days.

RADIATION

radiation therapy

Conformal radiation administered daily, M-F, to a total dose of 61.2 Gray in 34 fractions.

DRUG

Ascorbic Acid

Intravenous infusions of 87.5g of ascorbate administered three times weekly during radiation. After radiation, ascorbate is administered twice weekly through the end of cycle 6 of temozolomide.

Sponsors & Collaborators

  • Holden Comprehensive Cancer Center

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Gateway for Cancer Research

    collaborator OTHER

  • Bryan Allen

    lead OTHER

Principal Investigators

  • Bryan G. Allen, MD, PhD · Assistant Professor, Department of Radiation Oncology, The University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-13
Primary Completion
2026-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02344355 on ClinicalTrials.gov