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Trial record 5 of 12 for:    "Dietary Carbohydrates" | Recruiting, Not yet recruiting, Available Studies

Therapeutic Targeting of Sex Differences in Pediatric Brain Tumor Glycolysis

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ClinicalTrials.gov Identifier: NCT03591861
Recruitment Status : Not yet recruiting
First Posted : July 19, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Pediatric Brain Tumor Procedure: Ketogenic diet Drug: BCNU Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Targeting of Sex Differences in Pediatric Brain Tumor Glycolysis
Estimated Study Start Date : September 30, 2018
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
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 (3-4 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
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
Other Names:
  • Carmustine
  • BiCNU




Primary Outcome Measures :
  1. 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 [ Time Frame: Up to 2 years ]
    • 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

  2. Feasibility of combining a ketogenic diet with chemotherapy in children with relapsed brain tumors as measured by if at least 80% of the patients comply with the intervention [ Time Frame: Up to 2 years ]

    -The study will be defined as being feasible if at least 80% of the patients comply with the intervention as defined as achieving 80% of the targeted level of ketosis as assessed from laboratory measures and 80% of the planned BCNU doses

    --Please note that feasibility of the study is dependent on both primary outcome measures



Secondary Outcome Measures :
  1. Tolerability of combining a ketogenic diet with chemotherapy in male children with relapsed brain tumors versus female children with relapsed brain tumors as measured by toxicity [ Time Frame: Up to 2 years ]
    • All toxicities will be summarized by noting the count of participants who experience each toxicity
    • The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.

  2. Tumor response of male children with relapsed brain tumors to a ketogenic diet combined with chemotherapy versus female children with relapsed brain tumors as measured by progression-free survival (PFS) [ Time Frame: Up to 10 years ]
    • PFS is defined as the duration of time from start of treatment to time of radiographic progression or death due to any cause, whichever occurs first.
    • Progression will be defined by the Response Assessment in Neuro-Oncology (RANO) working group guideline.



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 months
  • Prior treatment with radiation alone, chemotherapy alone or combined radiation and chemotherapy is allowed.
  • No more than 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 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 IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591861


Contacts
Contact: Josh Rubin, M.D., Ph.D. (314) 286-2790 rubin_j@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Josh Rubin, M.D., Ph.D.    314-286-2790    rubin_j@wustl.edu   
Principal Investigator: Josh Rubin, M.D., Ph.D.         
Sub-Investigator: Joseph Ippolito, M.D., Ph.D.         
Sub-Investigator: Lin Lin Thio, M.D., Ph.D.         
Sub-Investigator: Jingqin (Rosy) Luo, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Josh Rubin, M.D., Ph.D. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03591861     History of Changes
Other Study ID Numbers: 201806141
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases