Ketogenic Diet in Treating Pediatric Patients with Brain Tumors Undergoing Chemotherapy
- Diagnosis of a recurrent primary brain tumor with no curative therapy available
- Measurable disease using pediatric Response Assessment in Neuro-Oncology Criteria (RANO) criteria
- Life expectancy > 12 weeks
- Prior treatment with radiation alone, chemotherapy alone or combined radiation and chemotherapy is allowed
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count >= 1,500/mcl
- Platelets >= 100,000/mcl
- Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x IULN
- Creatinine =< IULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Normal room air oxygenation must be documented. If room air oxygen saturation is less than 97%, a diffusion capacity of carbon monoxide (DLCO) of greater than 80%, must be demonstrated
- Karnofsky or Lansky performance status of >= 60
- Patients of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
- Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document (or that of legally authorized representative, if applicable)
- Patient does not have any of the following conditions as they are contraindicated for ketogenic diet: * Primary and secondary carnitine deficiency * Carnitine palmitoyltransferase I or II deficiency * Carnitine translocase deficiency * Mitochondrial beta-oxidation defects * Pyruvate carboxylase deficiency * Glycogen storage diseases * Ketolysis defects * Ketogenesis defects * Porphyria * Prolonged QT syndrome * Liver insufficiency * Renal insufficiency * Pancreatic insufficiency * Pulmonary insufficiency * Hyper insulinism
- Pregnant and/or breastfeeding. Female patients of childbearing potential must have a negative pregnancy test within 14 days of study entry
I. To determine whether combining a ketogenic diet with chemotherapy is feasible in children with relapsed brain tumors.
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.
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.
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 Phase Phase NA
Trial Type Treatment
Washington University School of Medicine
Andrew Stephen Cluster
- Primary ID 201806141
- Secondary IDs NCI-2018-01366
- Clinicaltrials.gov ID NCT03591861