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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
I can tolerate a test dose of vitamin C.
Select...
I was recently diagnosed with glioblastoma multiforme.
Select...
I can take care of myself but may not be able to do heavy physical work.
Select...
My diagnosis was confirmed through a surgical procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of grade 3, 4, & 5 adverse events
Secondary outcome measures
Overall survival
Time to progression
Side effects data
From 2013 Phase 3 trial • 397 Patients • NCT0000405478%
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 GI: NOS
12%
Late RT Toxicity: Other: NOS
12%
Hemoglobin decreased
12%
Alanine aminotransferase increased
9%
Gynaecomastia
8%
Urinary retention
7%
Pain-other
7%
Aspartate aminotransferase increased
6%
Rectal bleeding
6%
Constipation
6%
Leukopenia NOS
4%
Edema NOS
4%
Hematuria present
4%
Renal/GU-Other
3%
Arthralgia
3%
Blood creatinine increased
3%
Dyspnea NOS
3%
Dermatitis exfoliative NOS
2%
Nausea
2%
Hyperglycemia NOS
2%
Depression NEC
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Stomatitis
1%
Platelet count decreased
1%
Blood albumin decreased
1%
Weight decreased
1%
Anorexia
1%
Hypocalcemia
1%
Hyponatremia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy
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
Temozolomide
2010
Completed Phase 3
~1930
Radiation therapy
2013
Completed Phase 3
~2850
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,140 Total Patients Enrolled
322 Trials studying Glioblastoma
23,102 Patients Enrolled for Glioblastoma
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,575 Total Patients Enrolled
11 Trials studying Glioblastoma
607 Patients Enrolled for Glioblastoma
Joseph J. Cullen, MD, FACSLead Sponsor
3 Previous Clinical Trials
161 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, as the treatment involves risks to pregnancy.I do not have major brain or nerve diseases like multiple sclerosis.I am taking medication that cannot be replaced, such as flecainide or methadone.I have had radiation therapy to my head or neck before.I have had chemotherapy for my current brain tumor.My brain tumor has come back and is aggressive.I am on insulin, pending approval from the study's medical team.I am HIV-positive and understand high-dose vitamin C may affect my HIV medication levels.My treatment will start within 5 weeks after my surgery.I have been cancer-free for over 5 years, except for certain skin cancers or early-stage cervical or bladder cancer.I can tolerate a test dose of vitamin C.My diagnosis was confirmed through a surgical procedure.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am 18 years old or older.My recent blood test shows my bone marrow is working well.I was recently diagnosed with glioblastoma multiforme.I can take care of myself but may not be able to do heavy physical work.I have G6PD deficiency.
Research Study Groups:
This trial has the following groups:- Group 1: 15g Ascorbate
- Group 2: 25g Ascorbate
- Group 3: 75g Ascorbate
- Group 4: 87.5g Ascorbate
- Group 5: 50g arm
- Group 6: 62.5g
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Radiation therapy ever been tested as a form of treatment in any other clinical trials?
"Presently, there are 256 clinical trials that examine the use of Radiation therapy with 31 in Phase 3. Houston, Texas is home to a few of these studies but it can be found at 5204 other sites too."
Answered by AI
Is the enrollment period for this trial open?
"At present, this clinical trial is not open for enrollment. Initially posted on April 1st 2013 and most recently updated on July 21st 2022, individuals looking to participate in glioblastoma studies can find 442 active trials while those searching for radiation therapy should explore the 256 available options."
Answered by AI
What deleterious effects can arise from radiation treatment?
"Limited safety and efficacy data means that radiation therapy is only rated at a 1 on the scale of risk."
Answered by AI
What maladies is Radiation therapy frequently utilized to ameliorate?
"Radiation therapy is most commonly employed to address catarrh, yet can also be constructive in treating vitamin deficiency, advance directives and refractory neuroblastoma."
Answered by AI
Has there ever been a similar trial to this one previously conducted?
"Since its initial research conducted in 2002 under the sponsorship of Schering-Plough, Radiation therapy has been studied extensively. Its Phase 2 drug approval was granted after its debut study involving 60 participants. Currently, 256 studies are running across 46 countries and 1112 cities."
Answered by AI
How many participants are receiving treatment as part of this research?
"This clinical trial has stopped looking for participants and is no longer recruiting. It was posted on April 1st 2013 and last updated on July 21sth 2022, but there are currently 442 studies that accept glioblastoma patients as well as 256 trials involving radiation therapy still accepting volunteers."
Answered by AI
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