This pilot trial studies how well a ketogenic diet works in treating pediatric patients with brain tumors undergoing chemotherapy. Limiting the types of foods that contain glucose (such as high-carbohydrate foods) may be a way to reduce the growth of the tumors and improve the effect of other treatments, such as standard chemotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03591861.
PRIMARY OBJECTIVE:
I. To determine whether combining a ketogenic diet with chemotherapy is feasible in children with relapsed brain tumors.
SCONDARY OBJECTIVES:
I. To evaluate the feasibility and tolerability of combining a ketogenic diet with chemotherapy in male children with relapsed brain tumors versus female children with relapsed brain tumors.
II. To evaluate the tumor response of male children with relapsed brain tumors to a ketogenic diet combined with chemotherapy versus female children with relapsed brain tumors.
EXPLORATORY OBJECTIVES:
I. To evaluate the utility of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/magnetic resonance imaging (MRI) in predicting and monitoring therapeutic responses to a ketogenic diet in male children with relapsed brain tumors versus female children with relapsed brain tumors.
II. To determine the utility of metabolomic profiling and intracellular signaling analyses in predicting and monitoring therapeutic responses to a ketogenic diet in male children with relapsed brain tumors versus female children with relapsed brain tumors.
OUTLINE:
Patients receive ketogenic diet, beginning during a 3-5 day hospital admission and continuing until they do not tolerate it because of emesis, greater than 10% weight loss, or clinical or laboratory evidence of intolerability. Beginning within approximately 72 hours of achieving ketosis, patients also receive standard of care chemotherapy with carmustine intravenously (IV) over 2 hours every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up every 3 months for 1 year, every 6 months for 1 year, and then annually for up to 10 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationWashington University School of Medicine
Principal InvestigatorAndrew Stephen Cluster
