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High-Dose Vitamin C for Glioblastoma

Phase 2

Waitlist Available

Led By Bryan G. Allen, MD, PhD

Research Sponsored by Bryan Allen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Diagnosis must be made by surgical biopsy or excision

Must not have

Patients actively receiving insulin or using a finger-stick glucometer daily for blood glucose measurements

Recurrent high grade glioma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up monthly for 3 months, then every 3 months up to 5 years post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding high doses of vitamin C to the standard treatment for brain tumors can help improve outcomes.

Who is the study for?

Adults with newly diagnosed glioblastoma multiforme who can start treatment within 5 weeks of diagnosis, have adequate organ function and blood counts, are not pregnant or breastfeeding, do not have certain other health conditions or take specific drugs that could interfere with the study.

What is being tested?

The trial is testing high-dose ascorbate (vitamin C) combined with standard care including Temozolomide and radiation therapy for treating brain tumors. All participants will receive this combination to see if it improves outcomes.

What are the potential side effects?

Potential side effects may include reactions related to high doses of vitamin C such as gastrointestinal discomfort, kidney stones, or increased iron absorption. Standard treatments like Temozolomide and radiation also carry risks like nausea, fatigue, hair loss, and skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My diagnosis was confirmed through a surgical procedure.

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I was recently diagnosed with glioblastoma multiforme.

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I can tolerate a test dose of vitamin C.

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My treatment will start within 5 weeks after my surgery or biopsy.

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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use insulin or a daily finger-stick glucometer for my diabetes.

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My brain tumor has come back and is aggressive.

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I am taking medication that cannot be replaced, such as warfarin or methadone.

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I've had radiation therapy to my head or neck that overlapped areas.

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I have G6PD deficiency.

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I have another active cancer as diagnosed by my doctor.

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I am allergic to drugs similar to temozolomide.

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I have had chemotherapy for my current brain tumor.

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I am HIV-positive and understand high-dose vitamin C may affect my HIV medication levels.

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I do not have any serious illnesses that would interfere with the study or my safety.

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I do not have major brain or nerve diseases like multiple sclerosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ monthly for 3 months, then every 3 months up to 5 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~monthly for 3 months, then every 3 months up to 5 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly for 3 months, then every 3 months up to 5 years post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

Adverse Event Frequency

Progression Free Survival (PFS)

Other study objectives

Health-related Quality of Life (HRQOL)

Side effects data

From 2018 Phase 3 trial • 2028 Patients • NCT00002597

44%

Acute RT Toxicity: Bowel: NOS

29%

Hormone Toxicity: Hot flashes : NOS

26%

Late RT Toxicity: Bowel: NOS

24%

Hormone Toxicity: Impotence : NOS

18%

Late RT Toxicity: Bladder: NOS

17%

Hormone Toxicity: Hematologic : NOS

15%

Acute RT Toxicity: Bladder: NOS

13%

Acute RT Toxicity: Hematologic: NOS

13%

Late RT Toxicity: Hematologic: NOS

13%

Acute RT Toxicity: Other: NOS

Hormone Toxicity: Liver : NOS

Late RT Toxicity: Other: NOS

Late RT Toxicity: Other GU: NOS

100%

80%

60%

40%

20%

Study treatment Arm

Neoadjuvant TAS 2 Months Before and During RT

Radiation Therapy Alone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ascorbate, radiation, temozolomideExperimental Treatment3 Interventions

Concomitant therapy: Radiation therapy, oral temozolomide, and pharmacological ascorbate (ascorbic acid) infusions Adjuvant therapy: Oral temozolomide and pharmacological ascorbate (ascorbic acid) infusions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

Ascorbic Acid

2017

Completed Phase 4

~2280