Glioblastoma (GBM)Phase 1/2NCT02046187

Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma

A Phase 1/2 study testing Ketogenic Diet, Radiation therapy and Temozolomide in people with Glioblastoma (GBM), run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study aims to see if reducing blood sugar and increasing ketones (a metabolic product that comes from using fats for energy) can increase survival and enhance the the effects of standard radiation and chemotherapy treatments used to treat glioblastoma multiforme (GBM). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Glioblastoma (GBM)
What is being tested?: Ketogenic Diet, Radiation therapy and Temozolomide
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Oct 2013to Feb 2017
Phase: Phase 1/2
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adult patients, 18 - 80 years of age,
a single enhancing lesion of the brain with MRI appearance consistent with GBM
Pathologic confirmation of GBM
Zubrod Performance Scale (ZPS) < 2
Must be able to undergo MRI imaging with gadolinium
Must have access to a computer and the internet (to use KetoCalculator© on-line Database)

Who cannot join

unable to undergo MRI with gadolinium
genetic disorders of fat metabolism
patients receiving sodium valproate (may cause false ketone reading in urine)
diabetes
enrolled in another treatment trial for GBM

Trial locations and contacts

1 site in 1 country.

United States1 site

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013

Other trials in United States

About this study

Official title: Phase I/II Prospective Trial for Newly Diagnosed GBM, With Upfront Gross or Subtotal Resection, Followed by Ketogenic Diet With Radiotherapy and Concurrent Temodar(R) Chemotherapy Followed by Adjuvant Temodar(R) Chemotherapy.

Show that patients can tolerate the diet and maintain low blood glucose and high blood ketone levels.
Show if this diet enhances the effectiveness of standard treatment by prolonging survival of patients with a GBM.

Read the detailed description

The investigators propose to offer this study to patients with newly diagnosed glioblastoma multiforme (GBM) that undergo gross total resection (GTR) or subtotal resection (STR) of their tumor. Post-operatively, these patients and their families will be instructed in the implementation of the Ketogenic Diet (KD) and it will be started as soon as possible following surgery to achieve ketosis and reduction of blood sugar. Patients will receive standard chemoradiotherapy with fractionated external beam radiation (60Gy) and concurrent oral temozolomide chemotherapy followed by 12 adjuvant cycles of temozolomide chemotherapy on a standard dose schedule. Outcome measures of the study group will be compared to historic controls in the treatment arm from the European Organization for Research and Treatment of Cancer (EORTC) temozolomide study published by Roger Stupp et al, New England Journal of Medicine, March 10, 2005.

Note: Gross Total Resection (GTR), Subtotal Resection (STR), temozolomide (Temodar), and radiation therapy are routine care for GBM and are not an investigational component of this study.

Study end-points:

Primary: Ketogenic diet (KD) tolerance and compliance in brain tumor patients. The diet will be considered tolerable if the patient chooses to remain compliant. Compliance is monitored by the dietician using self reporting of diet, blood glucose and blood ketone levels.

Secondary: Overall survival, time to recurrence, health and therapy-related quality of life. Overall survival and progression free survival will be measured and compared to the historic controls who received chemoradiotherapy in standard dose scheduling.

Laboratory correlate: Molecular/immunohistochemical analysis of tumors that do and do not respond to a KD.

Conditions: Glioblastoma (GBM)
Being tested: Ketogenic Diet, Radiation therapy, Temozolomide
Keywords: Ketogenic Diet, Brain tumor, Glioma, Glioblastoma, Radiation, Chemotherapy, temozolomide
Medical subject headings: Glioblastoma, Brain Neoplasms, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ketogenic DietDietary supplement
Patients/families meet with the study dietician after surgery to discuss the ketogenic diet (KD), ask questions and plan clinic visits. Before radiation and chemotherapy begins, training takes place about the diet, meal planning and ketone/glucose monitoring. Ketosis will begin with the help of the dietitian one week before radiation begins. The patient will follow a classic 4/1 KD during chemo-radiation, followed by a modified Atkins diet during monthly chemotherapy. At the end of this period patients will follow a normal low carbohydrate diet similar to a Diabetic diet. The dietitian will follow the patient over the course of treatment. The patient will take and record ketone and glucose blood levels daily from start to end of treatment MRI scan, and meet with the dietitian weekly during radiation, at follow-up visits and on an as-needed basis.
Radiation therapyRadiation
Patients receive standard dose (60Gy/30 fractions) external beam radiation
TemozolomideDrug
Also called Temodar(R), chemotherapy
patients receive standard dose (75 mg/kg/day) temozolomide by mouth daily with radiation for 6 weeks. patients will also have standard maintenance dose (150-200 mg/kg/day) for five days each month for 12 cycles following radiation course.

Study groups in NCT02046187
Study group	Role	What they receive
Ketogenic Diet	Experimental	Subjects will adhere to a ketogenic diet prior to the start of and through radiation therapy course until the time of first scan after radiation ends. During radiation course, patients also take temozolomide daily. Receives: Dietary Supplement: Ketogenic Diet; Radiation: Radiation therapy; Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with adverse events
Number of participants with adverse events from initiation of ketogenic diet through end of radiation (while on ketogenic diet)
Measured: 8 weeks

Secondary outcomes (3)

overall survival
overall survival
Measured: 2 years
time to progression
time to progression
Measured: 2 years
quality of life
patient reported outcome of their quality of life using FACT-BR (version 4) survey
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Feb 2017

First posted27 Jan 2014 (estimated)
Study startOct 2013
Primary completionFeb 2017
Study completionFeb 2017

Why it stopped: excessive protocol deviations due to strict nature of diet requirements

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 Glioblastoma (GBM)Studies 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02046187
Sponsor's protocol ID: KD-13BN069
Status last verified: Jun 2021
First submitted: 17 Jan 2014
Last updated: 16 Jun 2021
Results posted: No
Data monitoring committee: Yes

Publications

Abdelwahab MG, Fenton KE, Preul MC, Rho JM, Lynch A, Stafford P, Scheck AC. The ketogenic diet is an effective adjuvant to radiation therapy for the treatment of malignant glioma. PLoS One. 2012;7(5):e36197. doi: 10.1371/journal.pone.0036197. Epub 2012 May 1.
PubMed 22563484
Scheck AC, Abdelwahab MG, Fenton KE, Stafford P. The ketogenic diet for the treatment of glioma: insights from genetic profiling. Epilepsy Res. 2012 Jul;100(3):327-37. doi: 10.1016/j.eplepsyres.2011.09.022. Epub 2011 Oct 22.
PubMed 22019313
Stafford P, Abdelwahab MG, Kim DY, Preul MC, Rho JM, Scheck AC. The ketogenic diet reverses gene expression patterns and reduces reactive oxygen species levels when used as an adjuvant therapy for glioma. Nutr Metab (Lond). 2010 Sep 10;7:74. doi: 10.1186/1743-7075-7-74.
PubMed 20831808

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
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PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
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All Glioblastoma (GBM) trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II Prospective Trial for Newly Diagnosed GBM, With Upfront Gross or Subtotal Resection, Followed by Ketogenic Diet With Radiotherapy and Concurrent Temodar(R) Chemotherapy Followed by Adjuvant Temodar(R) Chemotherapy.
ClinicalTrials.gov ID: NCT02046187
Acronym / sponsor ID: KD-13BN069
Conditions: Glioblastoma (GBM)
Keywords: Ketogenic Diet, Brain tumor, Glioma, Glioblastoma, Radiation, Chemotherapy, temozolomide
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: excessive protocol deviations due to strict nature of diet requirements
Enrolment: 14 participants (actual)
Lead sponsor: St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
Study start: Oct 2013 (actual)
Primary completion: Feb 2017 (actual)
Study completion: Feb 2017 (actual)
First posted: 27 Jan 2014 (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.

Show that patients can tolerate the diet and maintain low blood glucose and high blood ketone levels.
Show if this diet enhances the effectiveness of standard treatment by prolonging survival of patients with a GBM.

Detailed description

Note: Gross Total Resection (GTR), Subtotal Resection (STR), temozolomide (Temodar), and radiation therapy are routine care for GBM and are not an investigational component of this study.

Study end-points:

Laboratory correlate: Molecular/immunohistochemical analysis of tumors that do and do not respond to a KD.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ketogenic Diet	Experimental	Dietary Supplement: Ketogenic Diet, Radiation: Radiation therapy, Drug: TemozolomideSubjects will adhere to a ketogenic diet prior to the start of and through radiation therapy course until the time of first scan after radiation ends. During radiation course, patients also take temozolomide daily.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

adult patients, 18 - 80 years of age,
a single enhancing lesion of the brain with MRI appearance consistent with GBM
Pathologic confirmation of GBM
Zubrod Performance Scale (ZPS) < 2
Must be able to undergo MRI imaging with gadolinium

Key exclusion criteria (5 listed)

unable to undergo MRI with gadolinium
genetic disorders of fat metabolism
patients receiving sodium valproate (may cause false ketone reading in urine)
diabetes
enrolled in another treatment trial for GBM

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
Ketogenic DietPatients/families meet with the study dietician after surgery to discuss the ketogenic diet (KD), ask questions and plan clinic visits. Before radiation and chemotherapy begins, training takes place about the diet, meal planning and ketone/glucose monitoring. Ketosis will begin with the help of the dietitian one week before radiation begins. The patient will follow a classic 4/1 KD during chemo-radiation, followed by a modified Atkins diet during monthly chemotherapy. At the end of this period patients will follow a normal low carbohydrate diet similar to a Diabetic diet. The dietitian will follow the patient over the course of treatment. The patient will take and record ketone and glucose blood levels daily from start to end of treatment MRI scan, and meet with the dietitian weekly during radiation, at follow-up visits and on an as-needed basis.	Dietary supplement	Ketogenic Diet
Radiation therapyPatients receive standard dose (60Gy/30 fractions) external beam radiation	Radiation	Ketogenic Diet
TemozolomideAlso: Temodar(R), chemotherapypatients receive standard dose (75 mg/kg/day) temozolomide by mouth daily with radiation for 6 weeks. patients will also have standard maintenance dose (150-200 mg/kg/day) for five days each month for 12 cycles following radiation course.	Drug	Ketogenic Diet

Primary outcome

Number of participants with adverse events
Time frame: 8 weeks
Number of participants with adverse events from initiation of ketogenic diet through end of radiation (while on ketogenic diet)

3 secondary outcomes

overall survival
Time frame: 2 years
time to progression
Time frame: 2 years
quality of life
Time frame: 2 years

Results and safety

The study was stopped early (reason given: excessive protocol deviations due to strict nature of diet requirements). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
Background: PubMed 22563484Abdelwahab MG, Fenton KE, Preul MC, Rho JM, Lynch A, Stafford P, Scheck AC. The ketogenic diet is an effective adjuvant to radiation therapy for the treatment of malignant glioma. PLoS One. 2012;7(5):e36197. doi: 10.1371/journal.pone.0036197. Epub 2012 May 1.
Background: PubMed 22019313Scheck AC, Abdelwahab MG, Fenton KE, Stafford P. The ketogenic diet for the treatment of glioma: insights from genetic profiling. Epilepsy Res. 2012 Jul;100(3):327-37. doi: 10.1016/j.eplepsyres.2011.09.022. Epub 2011 Oct 22.
Background: PubMed 20831808Stafford P, Abdelwahab MG, Kim DY, Preul MC, Rho JM, Scheck AC. The ketogenic diet reverses gene expression patterns and reduces reactive oxygen species levels when used as an adjuvant therapy for glioma. Nutr Metab (Lond). 2010 Sep 10;7:74. doi: 10.1186/1743-7075-7-74.

Related trials for Glioblastoma (GBM)

Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
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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.

Adrienne C Scheck, PhD study chair

Barrow Neurological Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ketogenic Diet, Radiation therapy and Temozolomide in people with Glioblastoma (GBM), run by St. Joseph's Hospital and Medical Center, Phoenix 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Jun 2021. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: excessive protocol deviations due to strict nature of diet requirements). Results are not available in the source record.

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 participants with adverse events (time frame: 8 weeks). 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 NCT02046187, 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 16 Jun 2021.