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Trial record 4 of 10 for:    Ketogenic AND GBM

Ketogenic Diet Treatment Adjunctive to Radiation and Chemotherapy in Glioblastoma Multiforme: a Pilot Study (GBMXRT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Mid-Atlantic Epilepsy and Sleep Center, LLC
Sponsor:
Collaborator:
Neuroscience Research Foundation, Swickley,PA
Information provided by (Responsible Party):
Mid-Atlantic Epilepsy and Sleep Center, LLC
ClinicalTrials.gov Identifier:
NCT02302235
First received: November 24, 2014
Last updated: March 17, 2016
Last verified: March 2016
  Purpose
The goal of the present study is to evaluate efficacy, safety and tolerability of 4:1 ketogenic diet administered adjunctively to standard radiation and temozolomide chemotherapy in patients with GBM in a prospective, randomized open label study.

Condition Intervention Phase
Glioblastoma Multiforme of Brain
Other: Ketogenic Diet
Other: Standardized Diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ketogenic Diet Treatment Adjunctive to Radiation and Chemotherapy in Glioblastoma Multiforme: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Mid-Atlantic Epilepsy and Sleep Center, LLC:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 42
Study Start Date: February 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Standardized Diet
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.
Standardized diet
The subjects will be taken standard diet in a 1:1 ratio.
Other: Ketogenic Diet
Treatment will consist of ketogenic diet. KD will consist of 4:1 [fat] : [protein+carbohydrate] weight ratio with 1600 kcal restriction.
Other Name: KGD

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-65
  2. Ability and willingness to signed informed consent form
  3. Astrocytoma grade 4 (glioblastoma multiforme, GBM, histologically confirmed, WHO criteria)
  4. Documented surgical resection/debulking
  5. Measurable contrast-enhancing GBM by MRI imaging ≤ two weeks before screening or prior to surgery if done ≤ 2 months before
  6. Karnovsky Performance Score of 70 or more

Exclusion Criteria:

  1. 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)
  2. Prior treatment with any of the following: (a) small-molecule kinase inhibitor; (b) non-cytotoxic hormonal agent; (c) KD ≤6 months of enrollment
  3. Planned continued use of glucocorticoids
  4. 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)
  5. 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
  6. History of non-glioma malignancy other than:

    1. Surgically excised non-melanoma skin cancer or in situ carcinoma of the cervix
    2. A malignancy diagnosed ≥2 years ago if the subject has had no evidence of disease for 2 years prior to screening
  7. History of uncontrolled hyperlipidemia
  8. Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements
  9. History of human immunodeficiency virus, or hepatitis C
  10. Failure to recover from <CTCAE grade 2 toxicities related to prior therapy
  11. Pregnancy or breastfeeding
  12. Use of any investigational drug within 1 months of enrollment
  13. Inability or unwillingness of subject to give written informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02302235

Contacts
Contact: Pavel Klein, M.D. 3015309744 kleinp@epilepsydc.com
Contact: Ivana Tyrlikova, M.D. 3015309744 tyrlikovai@epilepsydc.com

Locations
United States, Maryland
MidAtlantic Epilepsy and Sleep Center Recruiting
Bethesda, Maryland, United States, 20817
Contact: Ivana Tyrlikova, MD    301-530-9744    tyrlikovai@epilepsydc.com   
Contact: Pavel Klein, MD    301-704-4925    kleinp@epilepsydc.com   
Principal Investigator: Pavel Klein, MD         
Sponsors and Collaborators
Mid-Atlantic Epilepsy and Sleep Center, LLC
Neuroscience Research Foundation, Swickley,PA
Investigators
Principal Investigator: Pavel Klein, M.D. Mid-Atlantic Epilepsy and Sleep Center
  More Information

Responsible Party: Mid-Atlantic Epilepsy and Sleep Center, LLC
ClinicalTrials.gov Identifier: NCT02302235     History of Changes
Other Study ID Numbers: maesc 006
Study First Received: November 24, 2014
Last Updated: March 17, 2016

Keywords provided by Mid-Atlantic Epilepsy and Sleep Center, LLC:
Glioblastoma multigorme
Ketogenic Diet
radiotherapy
chemotherapy
safety
efficiency

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on April 26, 2017