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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

Adverse Event Frequency

Progression Free Survival (PFS)

Other outcome measures

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

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

~1930

Ascorbic Acid

2017

Completed Phase 4

~2240

radiation therapy

1994

Completed Phase 3

~13390

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gateway for Cancer ResearchOTHER

45 Previous Clinical Trials

2,480 Total Patients Enrolled

1 Trials studying Glioblastoma

24 Patients Enrolled for Glioblastoma

Bryan AllenLead Sponsor

3 Previous Clinical Trials

41 Total Patients Enrolled

1 Trials studying Glioblastoma

12 Patients Enrolled for Glioblastoma

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,063 Total Patients Enrolled

322 Trials studying Glioblastoma

23,025 Patients Enrolled for Glioblastoma

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT02344355 — Phase 2

Glioblastoma Research Study Groups: ascorbate, radiation, temozolomide

Glioblastoma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT02344355 — Phase 2

Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02344355 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current vacancies for people who wish to participate in this clinical trial?

"Unfortunately, this particular clinical trial is not seeking new patients at the moment. According to the latest update on July 7th, 2022, it has been inactive for some time. However, there are 458 other trials for glioblastoma multiforme (gbm) and 271 radiation therapy studies that are still looking for participants."

Answered by AI

What are the risks associated with radiation therapy?

"While Phase 2 trials lack evidence for efficacy, there is some data suggesting that radiation therapy is safe. As such, our team has given it a rating of 2."

Answered by AI

How many individuals are being given this opportunity to participate in this clinical trial?

"As of now, this study is not recruiting any more patients. The trial was first posted on March 13th, 2017 and updated for the last time on July 7th, 2022. There are presently 458 trials actively searching for patients with glioblastoma multiforme (GBM) and 271 studies for radiation therapy that are also seeking participants."

Answered by AI

What type of cancer does radiation therapy usually target?

"While radiation therapy is most popular as a treatment for catarrh, it can also be taken to treat other conditions such as vitamin deficiency, advance directives, and refractory neuroblastoma."

Answered by AI

Is this study innovative or similar to other research?

"Radiation therapy has been an active area of research since the early 2000s. The first clinical trial was sponsored by Schering-Plough and involved 60 patients. After this initial study, radiation therapy received Phase 2 drug approval in 2002. As of now, there are 271 ongoing studies involving radiation therapy being conducted in 1125 different cities across 46 countries."

Answered by AI

Does this treatment have a precedent in other scientific research?

"271 clinical trials for radiation therapy are ongoing as of now, with 33 Phase 3 trials. Many of the studies will soon be completed, but there are still 5296 locations conducting research on this topic."

Answered by AI

Recent research and studies

Cancer CellJournal

O 2 ⋅− and H 2 O 2 -mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate

Schoenfeld, Joshua D., Zita A. Sibenaller, Kranti A. Mapuskar, Brett A. Wagner, Kimberly L. Cramer-Morales, Muhammad Furqan, Sonia Sandhu, et al.. 2017. “O 2 ⋅− and H 2 O 2 -mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate”. Cancer Cell. Elsevier BV. doi:10.1016/j.ccell.2017.02.018.

clinicaltrials.govStudy

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

Bryan Allen 2017. "A Phase 2 Trial of High-Dose Ascorbate in Glioblastoma Multiforme". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02344355.

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