AzTrials
AzTrials

Glioblastoma MultiformePhase 2NCT02344355

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

A Phase 2 study testing Temozolomide, radiation therapy and Ascorbic Acid in people with Glioblastoma Multiforme, run by Bryan Allen at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma Multiforme
What is being tested?
Temozolomide, radiation therapy and Ascorbic Acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
13 Mar 2017to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 15Show fewer
  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Pharmacological Ascorbate Combined With Radiation and Temozolomide in Glioblastoma Multiforme: A Phase 2 Trial

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.

Read the detailed 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:

  • 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.

Being tested
Temozolomide, radiation therapy, Ascorbic Acid
Keywords
Ascorbic Acid, temozolomide, radiation
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TemozolomideDrug

    Also called Temodar, Temodal

    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 therapyRadiation

    Also called EBRT, XRT, external beam radiation therapy

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

  • Ascorbic AcidDrug

    Also called Vitamin C, Ascorbate, Pharmacological Ascorbate, 67457-118-50

    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.

Study groups in NCT02344355
Study groupRoleWhat they receive
ascorbate, radiation, temozolomideExperimentalConcomitant therapy: Radiation therapy, oral temozolomide, and pharmacological ascorbate (ascorbic acid) infusions Adjuvant therapy: Oral temozolomide and pharmacological ascorbate (ascorbic acid) infusions
Receives: Drug: Temozolomide; Radiation: radiation therapy; Drug: Ascorbic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    From radiation day 1 until date of death from any cause.

    Measured: monthly up to 5 years post treatment

Secondary outcomes (2)

  1. Progression Free Survival (PFS)

    From radiation day 1 to documented disease progression in MRI imaging as described by the RANO criteria

    Measured: monthly up to 5 years post treatment

  2. Adverse Event Frequency

    Categorize and quantify using the Common Terminology Criteria for Adverse Events (CTCAE) v. 4 from radiation day 1 through 7 months post-radiation.

    Measured: monthly through 7 months post-radiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2015 (estimated)
  2. Study start13 Mar 2017
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02344355
Sponsor's protocol ID
201504786
Status last verified
Sep 2026
First submitted
16 Jan 2015
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data will be released publicly as per participant consent and IRB approval. Individual researchers should contact the research team for data sharing.

Publications

  • Schoenfeld JD, Sibenaller ZA, Mapuskar KA, Wagner BA, Cramer-Morales KL, Furqan M, Sandhu S, Carlisle TL, Smith MC, Abu Hejleh T, Berg DJ, Zhang J, Keech J, Parekh KR, Bhatia S, Monga V, Bodeker KL, Ahmann L, Vollstedt S, Brown H, Shanahan Kauffman EP, Schall ME, Hohl RJ, Clamon GH, Greenlee JD, Howard MA, Schultz MK, Smith BJ, Riley DP, Domann FE, Cullen JJ, Buettner GR, Buatti JM, Spitz DR, Allen BG. O2⋅- and H2O2-Mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate. Cancer Cell. 2017 Apr 10;31(4):487-500.e8. doi: 10.1016/j.ccell.2017.02.018. Epub 2017 Mar 30.

    PubMed 28366679

  • Petronek MS, Monga V, Bodeker KL, Kwofie M, Lee CY, Mapuskar KA, Stolwijk JM, Zaher A, Wagner BA, Smith MC, Vollstedt S, Brown H, Chandler ML, Lorack AC, Wulfekuhle JS, Sarkaria JN, Flynn RT, Greenlee JDW, Howard MA, Smith BJ, Jones KA, Buettner GR, Cullen JJ, St-Aubin J, Buatti JM, Magnotta VA, Spitz DR, Allen BG. Magnetic Resonance Imaging of Iron Metabolism with T2* Mapping Predicts an Enhanced Clinical Response to Pharmacologic Ascorbate in Patients with GBM. Clin Cancer Res. 2024 Jan 17;30(2):283-293. doi: 10.1158/1078-0432.CCR-22-3952.

    PubMed 37773633

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Temozolomide, radiation therapy and Ascorbic Acid in people with Glioblastoma Multiforme, run by Bryan Allen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: monthly up to 5 years post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02344355, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in