Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors
Summary: The current standard of care for glioblastoma multiforme (GBM), the most common
primary brain tumor in adults, includes surgical resection, radiation and chemotherapy.
Survival rarely exceeds 18 months. The investigators propose to test the hypothesis that
brain tumor cells are unable to utilize ketones as a source of energy when deprived of
glucose, due to mitochondrial dysfunction, whereas normal glia and neurons can survive this
metabolic stress. A nutritionally adequate but energy restricted, ketogenic diet (ERKD) to
deprive brain tumors of energy and resulting in death of glioma cells is promising.
ERKD-based therapy to manage brain cancer is both biologically plausible and supported by
data in animal models. A multidisciplinary team of oncologists, registered dietitians, and
physiologists will implement an ERKD therapy in two (2) GBM subjects for an 8 week, phase 1
clinical trial. After receiving standard medical care for GBM including biopsy or tumor
excision, ERKD therapy will be initiated for subjects during a one week inpatient admission
to Sparrow Hospital and supervised by registered dietitians experienced in implementing this
therapy. The objective of this trial is to determine whether the ERKD causes altered glucose
metabolism in gliomas and decreases tumor size in individuals with GBM as measured by
positron emission tomography/ computed tomography in the Department of Radiology at MSU.
Enzymes and signaling pathways that regulate metabolism and cell growth will be assessed in
initial and post-ERKD tumors using standard biochemical approaches.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
A CT-PET scan will be used to measure changes in brain tumor size.
Results of the metabolic therapy will be assessed by comparing CT-PET scans obtained at the beginning of the study with those after 6 and 12 weeks of metabolic therapy.
Kenneth Schwartz, MD
Michigan State University
United States: Institutional Review Board
|Michigan State University/Sparrow Hospital||E. Lansing, Michigan 48824|