Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-24 @ 12:57 PM
Study NCT ID:
NCT03591861
Status:
TERMINATED
Last Update Posted:
2022-12-12
First Post:
2018-06-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Targeting of Sex Differences in Pediatric Brain Tumor Glycolysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055423', 'term': 'Diet, Ketogenic'}, {'id': 'D002330', 'term': 'Carmustine'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2018-06-20', 'studyFirstSubmitQcDate': '2018-07-18', 'lastUpdatePostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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\n* Please note that feasibility of the study is dependent on both primary outcome measures'}, {'measure': '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', 'timeFrame': 'Up to 2 years', 'description': '-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\n\n--Please note that feasibility of the study is dependent on both primary outcome measures'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': 'Up to 2 years', 'description': '* All toxicities will be summarized by noting the count of participants who experience each toxicity\n* 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.'}, {'measure': '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)', 'timeFrame': 'Up to 10 years', 'description': '* 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.\n* Progression will be defined by the Response Assessment in Neuro-Oncology (RANO) working group guideline.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Brain Tumor']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of a recurrent primary brain tumor with no curative therapy available.\n* Measurable disease using pediatric Response Assessment in Neuro-Oncology Criteria (RANO) criteria.\n* Life expectancy \\> 12 weeks\n* Prior treatment with radiation alone, chemotherapy alone or combined radiation and chemotherapy is allowed.\n* Patient is \\< 21 years of age\n* Normal bone marrow and organ function as defined below:\n\n * Leukocytes ≥ 3,000/mcL\n * Absolute neutrophil count ≥ 1,500/mcl\n * Platelets ≥ 100,000/mcl\n * Total bilirubin ≤ 1.5 x IULN\n * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN\n * Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal\n * 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.\n* Karnofsky or Lansky performance score of ≥ 60\n* 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.\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* Patient does not have any of the following conditions as they are contraindicated for ketogenic diet:\n\n * Primary and secondary carnitine deficiency\n * Carnitine palmitoyltransferase I or II deficiency\n * Carnitine translocase deficiency\n * Mitochondrial β-oxidation defects\n * Pyruvate carboxylase deficiency\n * Glycogen storage diseases\n * Ketolysis defects\n * Ketogenesis defects\n * Porphyria\n * Prolonged QT syndrome\n * Liver insufficiency\n * Renal insufficiency\n * Pancreatic insufficiency\n * Pulmonary insufficiency\n * Hyper insulinism\n* Pregnant and/or breastfeeding. Female patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.'}, 'identificationModule': {'nctId': 'NCT03591861', 'briefTitle': 'Therapeutic Targeting of Sex Differences in Pediatric Brain Tumor Glycolysis', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Therapeutic Targeting of Sex Differences in Pediatric Brain Tumor Glycolysis', 'orgStudyIdInfo': {'id': '201806141'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketogenic Diet', 'description': '* Caregivers (and participating children) attend intro ketogenic diet class (4 - 30 min lectures)\n* Clinic visit with neurologist, nurse, and dietitian prior to hospital admission and then once every 3 months\n* Laboratory studies prior to hospital admission and then at each follow-up visit\n* Hospital admission (3-5 day) to start the ketogenic diet\n* Standard of care chemotherapy with BCNU for up to 2 years\n* Ketogenic diet can continue for up to 2 years', 'interventionNames': ['Procedure: Ketogenic diet', 'Drug: BCNU']}], 'interventions': [{'name': 'Ketogenic diet', 'type': 'PROCEDURE', 'description': '* 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.\n* 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.', 'armGroupLabels': ['Ketogenic Diet']}, {'name': 'BCNU', 'type': 'DRUG', 'otherNames': ['Carmustine', 'BiCNU'], 'description': '-Standard of care', 'armGroupLabels': ['Ketogenic Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Andrew Cluster, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}