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Ketogenic Diet as Adjunctive Treatment in Refractory/End-stage Glioblastoma Multiforme: a Pilot Study (KGDinGBM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Mid-Atlantic Epilepsy and Sleep Center, LLC
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Mid-Atlantic Epilepsy and Sleep Center, LLC
ClinicalTrials.gov Identifier:
NCT01865162
First received: May 24, 2013
Last updated: November 25, 2014
Last verified: May 2013
  Purpose

The first weekly KD meal package will be given to the patient at the study site. The patient will be instructed in how to process the week-long meal plan package content. Participants will measure urine ketone bodies with Ketostix 2x day and blood for glucose and ketone levels using self-administered Precision Xtra® Meter (Abbot Diabetes Care, Alameda, CA, USA) starting with the first day of the diet. Self-administered blood checks for glucose and ketone bodies will be done in fasted state in the morning and 2 hours post-prandially in the evening. Participants will be seen on day 7 of treatment by the study nutritionist and a study investigator-physician (separately) to review possible AEs, and for further education about the diet. Study staff will review and evaluate the participant's method of urine ketone and blood glucose and ketone levels testing. Subsequently, participants will be seen at one, 2 weeks, and 4 weeks after KG diet initiation, and then monthly. KD treatment will last until exit criteria are met or for 6 months, whichever comes first. Exit criteria are the primary outcome measures, the first of either (a) cerebral edema requiring steroid rescue therapy or (b) death.

Treatment will occur in outpatient office setting at the Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD. The location of subsequent treatment administration may change to hospital setting at Holy Cross Hospital should a patient need hospitalization during the study for any reason, as determined by the patient's clinical care needs.


Condition Intervention Phase
Glioblastoma Multiforme
Other: ketogenic diet
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ketogenic Diet as Adjunctive Treatment in Refractory/End-stage 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:
  • To evaluate the safety of ketogenic diet as adjunctive treatment of treatment-refractory glioblastoma multiforme. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Early treatment discontinuation, treatment compliance, 7-point Licker hunger scale, fasting lipid levels and fasting serum glucose and insulin levels


Secondary Outcome Measures:
  • To obtain pilot data on efficacy of ketogenic diet as adjunctive treatment of treatment-refractory glioblastoma multiforme [ Time Frame: one year ] [ Designated as safety issue: No ]
    The secondary outcome measures will be (i) survival time and (ii) time to cerebral edema requiring steroid rescue treatment

  • To evaluate tolerability of ketogenic diet as adjunctive treatment of treatment-refractory glioblastoma multiforme. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    the incidence of treatment-emergent AEs during treatment.


Estimated Enrollment: 6
Study Start Date: January 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ketogenic diet
Treatment will consist of ketogenic diet. KD will consist of 4:1 [fat] : [protein+carbohydrate] weight ratio with 1600 kcal restriction. The diet will be supplemented with vitamins, calcium, phosphorus, zinc and selenium supplements to meet the requirements of US Dietary Reference Intakes (DRI) standard.
Other: ketogenic diet
Treatment will consist of ketogenic diet. KD will consist of 4:1 [fat] : [protein+carbohydrate] weight ratio with 1600 kcal restriction. The diet will be supplemented with vitamins, calcium, phosphorus, zinc and selenium supplements to meet the requirements of US Dietary Reference Intakes (DRI) standard.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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 recurrence or progression after surgical resection/debulking, radiation and temozolamide chemotherapy.
  5. Measurable contrast-enhancing progressive or recurrent GBM by MRI imaging ≤ two weeks before screening.
  6. (a) ≥ 3months after completion of radiation; (b) 6 weeks from a nitrosourea chemotherapy; (c) ≥ weeks from a non-nitrosourea chemotherapy (all [a-c] in order to allow recovery from the potential of severe toxicity related to these treatments)
  7. 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:

    • 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.
  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: NCT01865162

Contacts
Contact: Pavel Klein, M.D. 301-530-9744 kleinp@epilepsydc.com
Contact: Ivana Tyrlikova, M.D. 301-530-9744 tyrlikovai@epilepsydc.com

Locations
United States, Maryland
MidAtlantic Epilepsy and Sleep Center Recruiting
Bethesda, Maryland, United States, 20817
Contact: Ivana Tyrlikova    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
University of Pittsburgh
Investigators
Principal Investigator: Pavel Klein, M.D. Director Mid-Atlantic Epilepsy and Sleep Center
  More Information

No publications provided

Responsible Party: Mid-Atlantic Epilepsy and Sleep Center, LLC
ClinicalTrials.gov Identifier: NCT01865162     History of Changes
Other Study ID Numbers: maes 002
Study First Received: May 24, 2013
Last Updated: November 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mid-Atlantic Epilepsy and Sleep Center, LLC:
Glioblastoma multiforme, ketogenic diet, neoplasm

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

ClinicalTrials.gov processed this record on November 25, 2014