Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-24 @ 12:57 PM
NCT ID:
NCT03591861
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT03591861
Study Brief:
Protocol Section:
NCT03591861