Therapeutic Targeting of Sex Differences in Pediatric Brain Tumor Glycolysis

  • STATUS
    Recruiting
  • End date
    May 31, 2034
  • participants needed
    15
  • sponsor
    Washington University School of Medicine
Updated on 4 October 2022

Summary

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.

Details
Condition Pediatric Brain Tumor
Treatment BCNU, Ketogenic diet
Clinical Study IdentifierNCT03591861
SponsorWashington University School of Medicine
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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