GlioblastomaPhase 1NCT01752491
A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme
A Phase 1 study testing Ascorbate, Temozolomide and Radiation therapy in people with Glioblastoma and GBM, run by Joseph J. Cullen, MD, FACS at 1 site in United States.
Trial summary
This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate (vitamin C) to standard radiation and chemotherapy for initial treatment of glioblastoma multiforme (GBM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, GBM, Glioblastoma Multiforme
- What is being tested?
- Ascorbate, Temozolomide and Radiation therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2013to 15 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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.
- Age ≥ 18 years
- ECOG performance status 0-2 (Karnofsky > 50%).
- A complete blood count and differential must be obtained within 21 days prior to the first dose of radiation, with adequate bone marrow functions as defined below:
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- Absolute neutrophil count (ANC) ≥ 1500 cells per mm3
- Platelets ≥ 100,000 per mm3
- Hemoglobin ≥ 8 g/dL
- Serum blood chemistries within 21 days before the first day of radiation, as defined below:
- Creatinine ≤ 2.0 mg
- Total bilirubin ≤ 1.5 mg/dL
- ALT (Alanine Aminotransferase)≤ 3 times the institutional upper limit of normal
- AST (Aspartate Aminotransferase) ≤ 3 times the institutional upper limit of normal
- Tolerate one text dose (15g) of ascorbate
- Not pregnant
- Ability to understand and willingness to sign a written informed consent document
Who cannot join
- Recurrent high grade glioma
- G6PD (glucose-6-phosphate dehydrogenase) deficiency
- Patients actively receiving insulin unless approved by the study medical monitor, study sponsor, and the study principal investigator.
- 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: flecainide, methadone, amphetamines, quinidine, and chlorpropamide. High dose ascorbic acid may affect urine acidification and, as a result, may affect clearance rates of these drugs.
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- Prior invasive malignancies (except non-melanomatous skin cancers and carcinoma in situ of the cervix or bladder) unless disease free for ≥ 5 years.
- Patients who have received prior chemotherapy (including Gliadel wafers) for the current glioma.
- Prior radiation therapy to the head or neck, which would result in overlap of radiation therapy fields.
- Patients may not be receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- 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.
- Known HIV-positive individuals. High-dose ascorbate acid is a known CYP450 3A4 (an enzyme pathway) 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 at the University of Iowa
Iowa City, Iowa, 52242
About this study
This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate (vitamin C) to standard radiation and chemotherapy for initial treatment of glioblastoma multiforme (GBM).
Read the detailed description
This phase 1 study will test the safety of adding high dose ascorbate (vitamin C) to standard chemoradiation and, after the radiation is completed, during 6 cycles of temozolomide.
Standard treatment for glioblastoma multiforme (GBM) involves surgery followed by radiation combined with temozolomide (a chemotherapy). After radiation, patients receive cycles of temozolomide (adjuvant chemotherapy)
Participants will:
- receive high doses of intravenous (IV) ascorbate three times a week during chemoradiation
- receive high doses of intravenous (IV) ascorbate twice a week during adjuvant chemotherapy (after radiation)
This is a phase 1 study will evaluate the side effects of adding this drug to the standard therapy. The dose given to a participant will be determined by how well other participants have tolerated the drug.
- Conditions
- Glioblastoma, GBM, Glioblastoma Multiforme
- Being tested
- Ascorbate, Temozolomide, Radiation therapy
- Keywords
- Ascorbate, Ascorbic acid, Vitamin C, Radiation, Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AscorbateDrug
Also called Ascorbic Acid, Vitamin C
Intravenous infusion of high-dose ascorbate
TemozolomideDrug
Also called Temodar
Oral chemotherapeutic
Radiation therapyRadiation
Also called External beam radiation therapy
External beam radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| 15g Ascorbate | Experimental | 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. Receives: Drug: Ascorbate; Drug: Temozolomide; Radiation: Radiation therapy |
| 25g Ascorbate | Experimental | 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. Receives: Drug: Ascorbate; Drug: Temozolomide; Radiation: Radiation therapy |
| 50g arm | Experimental | 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. Receives: Drug: Ascorbate; Drug: Temozolomide; Radiation: Radiation therapy |
| 62.5g | Experimental | 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. Receives: Drug: Ascorbate; Drug: Temozolomide; Radiation: Radiation therapy |
| 75g Ascorbate | Experimental | 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. Receives: Drug: Ascorbate; Drug: Temozolomide; Radiation: Radiation therapy |
| 87.5g Ascorbate | Experimental | 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. Receives: Drug: Ascorbate; Drug: Temozolomide; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of grade 3, 4, & 5 adverse events
Assess grade 3 and higher adverse events. Evaluate the frequency and severity against the published literature to determine the likely causality between ascorbate and the adverse event(s).
Measured: Weekly during therapy for up to 10 months
Secondary outcomes (2)
Time to progression
Time from the start of therapy (day 1, cycle 1) to documented disease progression in MRI imaging as described by MacDonald and colleagues.
Measured: monthly up to 5 years post treatment
Overall survival
From start of treatment (cycle 1, day 1) until the date of death from any cause.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study start1 Apr 2013
- Primary completion30 Nov 2015
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph J. Cullen, MD, FACS
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, John M. Buatti, University of Iowa
- Investigators
- John M. Buatti, MD, Principal investigator, Department of Radiation Oncology, The University of IowaJoseph J Cullen, MD, Study director, Professor of Surgery, The University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752491
- Sponsor's protocol ID
- 201211713
- Other IDs
- P30CA086862, U01CA140206
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2012
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data is shared through an NIH/NCI approved data sharing plan in compliance with subject's consent to sharing. Investigators interested in IPD should contact the sponsor, study PI, or study coordinator for more information.
Publications
Du J, Cullen JJ, Buettner GR. Ascorbic acid: chemistry, biology and the treatment of cancer. Biochim Biophys Acta. 2012 Dec;1826(2):443-57. doi: 10.1016/j.bbcan.2012.06.003. Epub 2012 Jun 20.
PubMed 22728050Du J, Martin SM, Levine M, Wagner BA, Buettner GR, Wang SH, Taghiyev AF, Du C, Knudson CM, Cullen JJ. Mechanisms of ascorbate-induced cytotoxicity in pancreatic cancer. Clin Cancer Res. 2010 Jan 15;16(2):509-20. doi: 10.1158/1078-0432.CCR-09-1713. Epub 2010 Jan 12.
PubMed 20068072Schoenfeld 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT01752491
- Acronym / sponsor ID
- 201211713
- Conditions
- Glioblastoma, GBM, Glioblastoma Multiforme
- Keywords
- Ascorbate, Ascorbic acid, Vitamin C, Radiation, Temozolomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Joseph J. Cullen, MD, FACSUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate (vitamin C) to standard radiation and chemotherapy for initial treatment of glioblastoma multiforme (GBM).
Detailed description
This phase 1 study will test the safety of adding high dose ascorbate (vitamin C) to standard chemoradiation and, after the radiation is completed, during 6 cycles of temozolomide.
Standard treatment for glioblastoma multiforme (GBM) involves surgery followed by radiation combined with temozolomide (a chemotherapy). After radiation, patients receive cycles of temozolomide (adjuvant chemotherapy)
Participants will:
- receive high doses of intravenous (IV) ascorbate three times a week during chemoradiation
- receive high doses of intravenous (IV) ascorbate twice a week during adjuvant chemotherapy (after radiation)
This is a phase 1 study will evaluate the side effects of adding this drug to the standard therapy. The dose given to a participant will be determined by how well other participants have tolerated the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 15g Ascorbate | Experimental | Drug: Ascorbate, Drug: Temozolomide, Radiation: Radiation therapyDuring 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. |
| 25g Ascorbate | Experimental | Drug: Ascorbate, Drug: Temozolomide, Radiation: Radiation therapyIf 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. |
| 50g arm | Experimental | Drug: Ascorbate, Drug: Temozolomide, Radiation: Radiation therapyIf 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. |
| 62.5g | Experimental | Drug: Ascorbate, Drug: Temozolomide, Radiation: Radiation therapyIf 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. |
| 75g Ascorbate | Experimental | Drug: Ascorbate, Drug: Temozolomide, Radiation: Radiation therapyIf 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. |
| 87.5g Ascorbate | Experimental | Drug: Ascorbate, Drug: Temozolomide, Radiation: Radiation therapyIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
- Age ≥ 18 years
- ECOG performance status 0-2 (Karnofsky > 50%).
Key exclusion criteria (13 listed)
- Recurrent high grade glioma
- G6PD (glucose-6-phosphate dehydrogenase) deficiency
- Patients actively receiving insulin unless approved by the study medical monitor, study sponsor, and the study principal investigator.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AscorbateAlso: Ascorbic Acid, Vitamin CIntravenous infusion of high-dose ascorbate | Drug | 15g Ascorbate, 25g Ascorbate, 50g arm, 62.5g, 75g Ascorbate, 87.5g Ascorbate |
| TemozolomideAlso: TemodarOral chemotherapeutic | Drug | 15g Ascorbate, 25g Ascorbate, 50g arm, 62.5g, 75g Ascorbate, 87.5g Ascorbate |
| Radiation therapyAlso: External beam radiation therapyExternal beam radiation therapy | Radiation | 15g Ascorbate, 25g Ascorbate, 50g arm, 62.5g, 75g Ascorbate, 87.5g Ascorbate |
Primary outcome
Number of grade 3, 4, & 5 adverse events
Time frame: Weekly during therapy for up to 10 months
Assess grade 3 and higher adverse events. Evaluate the frequency and severity against the published literature to determine the likely causality between ascorbate and the adverse event(s).
2 secondary outcomes
Time to progression
Time frame: monthly up to 5 years post treatment
Overall survival
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Background: PubMed 22728050Du J, Cullen JJ, Buettner GR. Ascorbic acid: chemistry, biology and the treatment of cancer. Biochim Biophys Acta. 2012 Dec;1826(2):443-57. doi: 10.1016/j.bbcan.2012.06.003. Epub 2012 Jun 20.
- Background: PubMed 20068072Du J, Martin SM, Levine M, Wagner BA, Buettner GR, Wang SH, Taghiyev AF, Du C, Knudson CM, Cullen JJ. Mechanisms of ascorbate-induced cytotoxicity in pancreatic cancer. Clin Cancer Res. 2010 Jan 15;16(2):509-20. doi: 10.1158/1078-0432.CCR-09-1713. Epub 2010 Jan 12.
- Results publication: PubMed 28366679Schoenfeld 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.
- Individual participant dataSharing planned: Yes. Individual participant data is shared through an NIH/NCI approved data sharing plan in compliance with subject's consent to sharing. Investigators interested in IPD should contact the sponsor, study PI, or study coordinator for more information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M. Buatti, MD principal investigator
Department of Radiation Oncology, The University of Iowa
Joseph J Cullen, MD study director
Professor of Surgery, The University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ascorbate, Temozolomide and Radiation therapy in people with Glioblastoma and GBM, run by Joseph J. Cullen, MD, FACS 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 17 inclusion and 13 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: finished, as of the sponsor's last update on 20 Dec 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of grade 3, 4, & 5 adverse events (time frame: Weekly during therapy for up to 10 months). 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 NCT01752491, which also lists 3 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 20 Dec 2024.