Clinical Trial Finder

Inclusion Criteria:

• - 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.

• - Patient is < 21 years of age.

• - Normal bone marrow and organ function as defined below: - Leukocytes ≥ 3,000/mcL.

• - Absolute neutrophil count ≥ 1,500/mcl.

• - Platelets ≥ 100,000/mcl.

• - Total bilirubin ≤ 1.5 x IULN.

• - AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN.

• - Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 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 score 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 IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

• - 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 β-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.

Arms

Experimental: Ketogenic Diet

Caregivers (and participating children) attend intro ketogenic diet class (4 - 30 min lectures) Clinic visit with neurologist, nurse, and dietitian prior to hospital admission and then once every 3 months Laboratory studies prior to hospital admission and then at each follow-up visit Hospital admission (3-5 day) to start the ketogenic diet Standard of care chemotherapy with BCNU for up to 2 years Ketogenic diet can continue for up to 2 years

Interventions

Procedure: - Ketogenic diet

Children under 2 years will immediately start on a full calorie classical 3:1 ketogenic diet. The 3:1 ratio indicates that the diet contains 3 g of fat for every 1 g of protein + carbohydrate, which results in about 87% of calories coming from fat. Children 2 years or older will skip breakfast and lunch on the day of admission but start a full calorie 3:1 ketogenic diet at dinner.

Drug: - BCNU

-Standard of care