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Vitamin

High-Dose Vitamin C + Standard Therapy for Glioblastoma

Phase 1

Waitlist Available

Led By John M. Buatti, MD

Research Sponsored by Joseph J. Cullen, MD, FACS

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Tolerate one text dose (15g) of ascorbate

Must not have

Pregnant women are excluded from this study because ionizing radiation is a known teratogen, and temozolomide is a Class D agent with the potential for teratogenic or abortifacient effects

Significant co-morbid central nervous system disease, including but not limited to, multiple sclerosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it's safe to add high doses of vitamin C to standard radiation and chemotherapy for brain cancer.

Who is the study for?

Adults over 18 with newly diagnosed glioblastoma multiforme can join if they start treatment within 5 weeks of surgery, have decent physical function and organ health, aren't pregnant, don't have certain drug dependencies or other cancers in the last 5 years, and haven't had prior chemo for glioma or head/neck radiation.

What is being tested?

The trial is testing high-dose vitamin C (ascorbate) added to standard radiation and chemotherapy in treating brain cancer called glioblastoma. It's a phase I study which means it's checking safety levels for the first time in humans.

What are the potential side effects?

Potential side effects may include digestive discomfort due to high doses of vitamin C, typical chemotherapy-related issues like nausea and fatigue, as well as skin irritation from radiation therapy.

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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I can tolerate a test dose of vitamin C.

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I was recently diagnosed with glioblastoma multiforme.

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I can take care of myself but may not be able to do heavy physical work.

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My diagnosis was confirmed through a surgical procedure.

Exclusion Criteria

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

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I am not pregnant, as the treatment involves risks to pregnancy.

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

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

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I have had radiation therapy to my head or neck before.

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I have had chemotherapy for my current brain tumor.

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My brain tumor has come back and is aggressive.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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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 have G6PD deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Number of grade 3, 4, & 5 adverse events

Secondary study objectives

Overall survival

Time to progression

Side effects data

From 2013 Phase 3 trial • 397 Patients • NCT00004054

78%

Menopausal symptoms

60%

Urinary frequency

52%

Impotence

47%

Late RT Toxicity: Bladder: NOS

39%

Diarrhea NOS

27%

Late RT Toxicity: Bowel: NOS

26%

Fatigue

26%

Late RT Toxicity: Other GU: NOS

21%

Proctitis NOS

21%

Dysuria

14%

Libido decreased

14%

Dermatitis radiation NOS

12%

Late RT Toxicity: Other: NOS

12%

Late RT Toxicity: Other GI: NOS

12%

Hemoglobin decreased

12%

Alanine aminotransferase increased

Gynaecomastia

Urinary retention

Pain-other

Aspartate aminotransferase increased

Rectal bleeding

Constipation

Leukopenia NOS

Edema NOS

Hematuria present

Renal/GU-Other

Arthralgia

Blood creatinine increased

Dyspnea NOS

Dermatitis exfoliative NOS

Depression NEC

Nausea

Hyperglycemia NOS

Lymphopenia

Myalgia

Peripheral sensory neuropathy

Platelet count decreased

Hyponatremia

Hypocalcemia

Blood albumin decreased

Stomatitis

Weight decreased

Anorexia

Hematologic-Other

Neutropenia

Alopecia

100%

80%

60%

40%

20%

Study treatment Arm

Hormones and RT

Hormones and RT Plus Chemotherapy

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: 87.5g AscorbateExperimental Treatment3 Interventions

If the 75g arm is tolerated, the study opens the 87.5g arm. During radiation therapy: * Radiation: 61.2 Gray (1.8 Gy/fraction/day), 5 days/wk, for about 8 weeks. * Temozolomide: 75 mg/m2, taken orally, once every day, until radiation is completed. * Ascorbate: 87.5 g administered by IV three times a week until 1 month after radiation is completed (about 12 weeks). After radiation therapy: * Temozolomide: Starting 1 month after radiation. 150 mg/m2 and then 200 mg/m2 daily. Starting 28 days after the completion of radiation therapy. Taken for 5 days followed by 23 days of rest for 6 cycles. * Ascorbate: escalating weekly doses of ascorbate (up to 125 grams) to target a serum level of 350 mg/dL (20 mM). Ascorbate is administered twice weekly, each week, for up to 6 months.

Group II: 75g AscorbateExperimental Treatment3 Interventions

If the 62.5g arm is tolerated, the study opens the 75g arm. During radiation therapy: * Radiation: 61.2 Gray (1.8 Gy/fraction/day), 5 days/wk, for about 8 weeks. * Temozolomide: 75 mg/m2, taken orally, once every day, until radiation is completed. * Ascorbate: 75 g administered by IV three times a week until 1 month after radiation is completed (about 12 weeks). After radiation therapy: * Temozolomide: Starting 1 month after radiation. 150 mg/m2 and then 200 mg/m2 daily. Starting 28 days after the completion of radiation therapy. Taken for 5 days followed by 23 days of rest for 6 cycles. * Ascorbate: escalating weekly doses of ascorbate (up to 125 grams) to target a serum level of 350 mg/dL (20 mM). Ascorbate is administered twice weekly, each week, for up to 6 months.

Group III: 62.5gExperimental Treatment3 Interventions

If the 50g arm is tolerated, the study opens the 62.5g arm. During radiation therapy: * Radiation: 61.2 Gray (1.8 Gy/fraction/day), 5 days/wk, for about 8 weeks. * Temozolomide: 75 mg/m2, taken orally, once every day, until radiation is completed. * Ascorbate: 62.5 g administered by IV three times a week until 1 month after radiation is completed (about 12 weeks). After radiation therapy: * Temozolomide: Starting 1 month after radiation. 150 mg/m2 and then 200 mg/m2 daily. Starting 28 days after the completion of radiation therapy. Taken for 5 days followed by 23 days of rest for 6 cycles. * Ascorbate: escalating weekly doses of ascorbate (up to 125 grams) to target a serum level of 350 mg/dL (20 mM). Ascorbate is administered twice weekly, each week, for up to 6 months.

Group IV: 50g armExperimental Treatment3 Interventions

If the 25g arm is tolerated, the study opens the 50g arm. During radiation therapy: * Radiation: 61.2 Gray (1.8 Gy/fraction/day), 5 days/wk, for about 8 weeks. * Temozolomide: 75 mg/m2, taken orally, once every day, until radiation is completed. * Ascorbate: 50 g administered by IV three times a week until 1 month after radiation is completed (about 12 weeks). After radiation therapy: * Temozolomide: Starting 1 month after radiation. 150 mg/m2 and then 200 mg/m2 daily. Starting 28 days after the completion of radiation therapy. Taken for 5 days followed by 23 days of rest for 6 cycles. * Ascorbate: escalating weekly doses of ascorbate (up to 125 grams) to target a serum level of 350 mg/dL (20 mM). Ascorbate is administered twice weekly, each week, for up to 6 months.

Group V: 25g AscorbateExperimental Treatment3 Interventions

If the 15g arm is tolerated, the study opens the 25g arm. During radiation therapy: * Radiation: 61.2 Gray (1.8 Gy/fraction/day), 5 days/wk, for about 8 weeks. * Temozolomide: 75 mg/m2, taken orally, once every day, until radiation is completed. * Ascorbate: 25 g administered by IV three times/wk until 1 month after radiation is completed (about 12 weeks). After radiation therapy: * Temozolomide: Starting 1 month after radiation. 150 mg/m2 and then 200 mg/m2 daily. Starting 28 days after the completion of radiation therapy. Taken for 5 days followed by 23 days of rest for 6 cycles. * Ascorbate: escalating weekly doses of ascorbate (up to 125 grams) to target a serum level of 350 mg/dL (20 mM). Ascorbate is administered twice weekly, each week, for up to 6 months.

Group VI: 15g AscorbateExperimental Treatment3 Interventions

During radiation therapy: * Radiation: 61.2 Gray (1.8 Gray / fraction / day), 5 days/week, for approximately 8 weeks. * Temozolomide: 75 mg/m2, taken orally, once daily, every day, until radiation is completed. * Ascorbate: 15 g administered by IV three times a week until 1 month after radiation is completed (approximately 12 weeks). After radiation therapy: * Temozolomide: Starting 1 month after radiation. 150 mg/m2 and then 200 mg/m2 daily. Starting 28 days after the completion of radiation therapy. Taken for 5 days followed by 23 days of rest for 6 cycles. * Ascorbate: escalating weekly doses of ascorbate (up to 125 grams) to target a serum level of 350 mg/dL (20 mM). Ascorbate is administered twice weekly, each week, for up to 6 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ascorbate

2019

Completed Phase 2

~30

Temozolomide

2010

Completed Phase 3

~1880