Clinical trial · Interventional
Therapeutic Targeting of Sex Differences in Pediatric Brain Tumor Glycolysis
NCT03591861CI-TRIAL-00062630terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
The investigators will develop the concept of a sex-specific therapeutic intervention for gliomas that is based upon dietary carbohydrate restriction. The investigators will integrate metabolomics tools and FDG-PET imaging to validate the ketogenic diet on a sex-specific basis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Brain Tumor | Childhood Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCNU | Drug | Carmustine | ALIAS |
| Ketogenic diet | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ketogenic Diet
- description
- * 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
- interventionNames
- Procedure: Ketogenic diet
- Drug: BCNU
Primary outcomes (2)
- measure
- Feasibility of combining a ketogenic diet with chemotherapy in children with relapsed brain tumors as measured by the number of patients who can recruited with 3 years
- timeFrame
- Through completion of enrollment of all participants (estimated to be 3 years)
- description
- * The study will be defined as being feasible if all 15 patients can be recruited within 3 years * Please note that feasibility of the study is dependent on both primary outcome measures
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.