- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02302235
Ketogenic Diet Treatment Adjunctive to Radiation and Chemotherapy in Glioblastoma Multiforme: a Pilot Study (GBMXRT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary aims of the study will be to 1) To evaluate efficacy of ketogenic diet as adjunctive treatment of radiation treatment in glioblastoma multiforme. 2) To evaluate the safety of ketogenic diet as adjunctive treatment of radiation treatment in glioblastoma multiforme. Secondary aim will be to evaluate tolerability of ketogenic diet as adjunctive treatment of radiation treatment in glioblastoma multiforme.
Participants will be seen at one, 2 weeks, and 4 weeks after KG diet initiation, and then monthly until month 6 after diet initiation, then every 2 months until 2 years after treatment initiation or death, then every 3 months until 3 years after treatment initiation or death. KD treatment will last for 6 months or until exit criteria are met, whichever comes first. Exit criteria are the primary outcome measures, the first of either (a) MRI tumor progression or (b) death. Secondary outcome measures will include treatment compliance, hunger scale scores, fasting serum glucose and BOH levels and occurrence of adverse events.
Patients with documented tumor progression will receive standard care for progressive GBM as directed by their treating oncologist, independent of the study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20817
- Midatlantic Epilepsy and Sleep Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-65
- Ability and willingness to signed informed consent form
- Astrocytoma grade 4 (glioblastoma multiforme, GBM, histologically confirmed, WHO criteria)
- Documented surgical resection/debulking
- Measurable contrast-enhancing GBM by MRI imaging ≤ two weeks before screening or prior to surgery if done ≤ 2 months before
- Karnovsky Performance Score of 70 or more
Exclusion Criteria:
- Acute intracranial or intratumoral hemorrhage > Grade 1 either by MRI or CT scan ≤2 weeks of screening. (Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin may enter the study)
- Prior treatment with any of the following: (a) small-molecule kinase inhibitor; (b) non-cytotoxic hormonal agent; (c) KD ≤6 months of enrollment
- Planned continued use of glucocorticoids
- Anticoagulation treatment with ≥ 1 mg/day coumadin ≤ 7 days prior to screening (low-dose [≤ 1 mg/day] coumadin, heparin, and low-molecular-weight heparin are permitted)
- Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis
History of non-glioma malignancy other than:
- Surgically excised non-melanoma skin cancer or in situ carcinoma of the cervix
- A malignancy diagnosed ≥2 years ago if the subject has had no evidence of disease for 2 years prior to screening
- History of uncontrolled hyperlipidemia
- Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements
- History of human immunodeficiency virus, or hepatitis C
- Failure to recover from <CTCAE grade 2 toxicities related to prior therapy
- Pregnancy or breastfeeding
- Use of any investigational drug within 1 months of enrollment
- Inability or unwillingness of subject to give written informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ketogenic Diet
Treatment will consist of ketogenic diet.
KGD will consist of 4:1 [fat] : [protein+carbohydrate] weight ratio with 1600 kcal restriction.
Diet will be started at the time of initiation of radiation treatment.
|
Participants with GBM treated with radiation and temozolomide after surgical debulking treatment.
The subjects will be taken standard diet in a 1:1 ratio.
Diet will be started at the time of initiation of radiation treatment.
|
Other: Standardized diet
The subjects will be taken standard diet in a 1:1 ratio.
|
Treatment will consist of ketogenic diet.
KD will consist of 4:1 [fat] : [protein+carbohydrate] weight ratio with 1600 kcal restriction.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
survival time
Time Frame: 6 months
|
We hope to achieve a substantial difference in both survival time and time to recurrence between the KD and non-KD treatment groups.
Survival time of 3 years from treatment initiation and tumor progression-free time of 2.5 years from treatment initiation would be extraordinary compared to historical data.
|
6 months
|
time to radiological (MRI) tumor progression
Time Frame: 6 months
|
MRI outcome will be assessed by the radiographic assessment in neuro-oncology criteria based on contrast-enhanced cranial MRI scans evaluating measureable disease, measured as the sum of products of perpendicular diameters (bi-dimensional measurements) of all measurable enhancing lesions and non-measurable disease.
|
6 months
|
The incidence of treatment-emergent adverse events during treatment
Time Frame: 6 months
|
Incidence of treatment-emergent adverse events changes in laboratory evaluations, changes in physical examination findings will be compared between the KD and control treatment groups
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerability of ketogenic diet: Rate of early discontinuation of subjects from the diet because of intolerability, defined as unwillingness by the subject to continue with the diet because of possible diet related side effects
Time Frame: 6 months
|
Rate of early discontinuation of subjects from the diet because of intolerability, defined as unwillingness by the subject to continue with the diet because of possible diet related side effects will be evaluated using descriptive statistics
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Pavel Klein, M.D., Mid-Atlantic Epilepsy and Sleep Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- maesc 006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glioblastoma Multiforme of Brain
-
University Hospital, GenevaActive, not recruitingGlioblastoma Multiforme | Glioblastoma Multiforme of Brain | Glioma of Brain | Glioblastoma, AdultSwitzerland
-
Jasper GerritsenMassachusetts General Hospital; Universitaire Ziekenhuizen KU Leuven; University... and other collaboratorsRecruitingGlioblastoma | Glioblastoma Multiforme | Recurrent Glioblastoma | Glioblastoma, IDH-wildtype | Glioblastoma Multiforme, Adult | Glioblastoma Multiforme of Brain | Astrocytoma of Brain | Astrocytoma, MalignantUnited States, Germany, Netherlands, Switzerland, Belgium
-
Milton S. Hershey Medical CenterRecruitingGlioblastoma | Glioblastoma Multiforme | Glioblastoma Multiforme, Adult | Glioblastoma Multiforme of BrainUnited States
-
Jasper GerritsenMassachusetts General Hospital; Universitaire Ziekenhuizen KU Leuven; University... and other collaboratorsRecruitingGlioblastoma | Glioblastoma Multiforme | Glioblastoma, IDH-wildtype | Glioblastoma Multiforme, Adult | Glioblastoma Multiforme of BrainUnited States, Belgium, Switzerland, Germany, Netherlands
-
Milton S. Hershey Medical CenterNational Cancer Institute (NCI)RecruitingGlioblastoma | Glioblastoma Multiforme | Glioblastoma Multiforme, Adult | Glioblastoma Multiforme of BrainUnited States
-
Mashhad University of Medical SciencesUnknownEfficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade GliomaGlioblastoma Multiforme of Brain | Anaplastic Astrocytoma of BrainIran, Islamic Republic of
-
TVAX BiomedicalFDA Office of Orphan Products DevelopmentRecruitingGlioblastoma Multiforme of BrainUnited States
-
Shenzhen Geno-Immune Medical InstituteEnrolling by invitationGlioblastoma Multiforme | Glioblastoma Multiforme of BrainChina
-
University of Roma La SapienzaCompletedGlioblastoma Multiforme of Brain
-
Imperial College LondonRecruitingGlioblastoma Multiforme of BrainUnited Kingdom
Clinical Trials on Standardized Diet
-
Stanford UniversityCompleted
-
University of Alabama at BirminghamCompletedObesity | Nocturnal Blood Pressure | Natriuretic PeptidesUnited States
-
Wageningen UniversityCompletedGlucose Metabolism | Postprandial Glucose ResponsesNetherlands
-
Maastricht University Medical CenterCompletedSingle Bout of Resistance Type Exercise | Standardized DietNetherlands
-
Wake Forest University Health SciencesTerminatedSedentary Lifestyle | PreDiabetesUnited States
-
University Hospital Inselspital, BerneSwiss National Science FoundationCompletedGrowth Hormone Deficiency | Insulin Sensitivity | Aerobic Exercise | Ectopic Lipids | Fat LoadSwitzerland
-
Diakonhjemmet HospitalAarhus University Hospital; University Hospital, UmeåRecruitingRheumatoid Arthritis | Psoriatic Arthritis | SpondyloarthritisNorway
-
University of ArkansasCompleted
-
University of SydneyActive, not recruiting
-
Mid-Atlantic Epilepsy and Sleep Center, LLCUnknownObesity | Diabetes | Obstructive Sleep ApneaUnited States