[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100415929":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":28,"locations":35,"responsibleParty":419,"collaborators":33,"id":423,"slug":424,"hasResults":425,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":33,"eligibilityCriteria":429,"healthyVolunteers":425,"sex":430,"minAge":33,"maxAge":431,"enrollmentInfo":432,"targetDuration":33,"studyType":435,"phases":436,"briefSummary":438,"conditions":439,"keywords":33,"overallStatus":38,"whyStopped":33,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":450},{"fullName":5,"class":6},"Milton S. Hershey Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Difluoromethylornithine (DFMO)","EXPERIMENTAL","study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 2500 mg\u002Fm2 BID on each day of study.",[13],"Drug: Difluoromethylornithine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Difluoromethylornithine","DFMO (difluoromethylornithine is an inhibitor of ornithine decarboxylase (ODC) designated chemically as 2-(difluoromethyl)-DL-ornithine monohydrochloride monohydrate.\n\nThe dosage form to be used in this study is provided as a convex tablet containing 192 mg eflornithine (equivalent to 250 mg of eflornithine HCl, monohydrate). The tablets are packaged and sealed in opaque white HDPE bottles, and each bottle contains 100 tablets. The DMFO tablets are supplied by USWorldMeds (USWM).\n\nThe tablets are to be stored at room temperature (20-250C).",[9],[21,22],"Eflornithine","DFMO",[24],{"name":25,"affiliation":26,"role":27},"Michael A Huang, MD","Beat Childhood Cancer","STUDY_CHAIR",[29],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"BCC Enroll","CONTACT","7175310003",null,"BCCEnroll@pennstatehealth.psu.edu",[36,57,73,88,103,119,135,150,165,180,196,212,228,242,258,273,289,305,321,337,353,369,385,401],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Arkansas Children's Hospital","RECRUITING","Little Rock","Arkansas","72202","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-92.28959,34.74648,{"lat":48,"lon":47},[51,54],{"name":52,"role":31,"phone":33,"phoneExt":33,"email":53},"Susan Hall","HallSF@archildrens.org",{"name":55,"role":56,"phone":33,"phoneExt":33,"email":33},"Kevin 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Russell",{"facility":306,"status":38,"city":307,"state":308,"zip":309,"country":42,"countryCode":43,"cosmosGeoPoint":310,"geoPoint":314,"contacts":315},"University of Oklahoma","Oklahoma City","Oklahoma","73104",{"type":45,"coordinates":311},[312,313],-97.51643,35.46756,{"lat":313,"lon":312},[316,319],{"name":317,"role":31,"phone":33,"phoneExt":33,"email":318},"Christina Gonzalez","Christina-gonzalez@ou.edu",{"name":320,"role":56,"phone":33,"phoneExt":33,"email":33},"Rene McNall-Knapp",{"facility":322,"status":38,"city":323,"state":324,"zip":325,"country":42,"countryCode":43,"cosmosGeoPoint":326,"geoPoint":330,"contacts":331},"Randall Children's Hospital","Portland","Oregon","97227",{"type":45,"coordinates":327},[328,329],-122.67621,45.52345,{"lat":329,"lon":328},[332,335],{"name":333,"role":31,"phone":33,"phoneExt":33,"email":334},"Aaron White","AJWHITE@lhs.org",{"name":336,"role":56,"phone":33,"phoneExt":33,"email":33},"Jason 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Hershey Medical Center and Children's Hospital","Hershey","Pennsylvania","17033",{"type":45,"coordinates":343},[344,345],-76.65025,40.28592,{"lat":345,"lon":344},[348,351],{"name":349,"role":31,"phone":33,"phoneExt":33,"email":350},"Penn State Clinical Trials","ExtractClinicalTrials@pennstatehealth.psu.edu",{"name":352,"role":56,"phone":33,"phoneExt":33,"email":33},"Valerie Brown",{"facility":354,"status":38,"city":355,"state":356,"zip":357,"country":42,"countryCode":43,"cosmosGeoPoint":358,"geoPoint":362,"contacts":363},"Hasbro Children's Hospital","Providence","Rhode Island","02903",{"type":45,"coordinates":359},[360,361],-71.41283,41.82399,{"lat":361,"lon":360},[364,367],{"name":365,"role":31,"phone":33,"phoneExt":33,"email":366},"Christopher Bouressa","cbouressa@lifespan.org",{"name":368,"role":56,"phone":33,"phoneExt":33,"email":33},"Bradley DeNardo",{"facility":370,"status":38,"city":371,"state":372,"zip":373,"country":42,"countryCode":43,"cosmosGeoPoint":374,"geoPoint":378,"contacts":379},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":45,"coordinates":375},[376,377],-79.93275,32.77632,{"lat":377,"lon":376},[380,383],{"name":381,"role":31,"phone":33,"phoneExt":33,"email":382},"Shanta Salzar, MD","salzers@musc.edu",{"name":384,"role":56,"phone":33,"phoneExt":33,"email":33},"Jaqueline Kraveka",{"facility":386,"status":38,"city":387,"state":388,"zip":389,"country":42,"countryCode":43,"cosmosGeoPoint":390,"geoPoint":394,"contacts":395},"Dell Children's Blood and Cancer Center","Austin","Texas","78723",{"type":45,"coordinates":391},[392,393],-97.74306,30.26715,{"lat":393,"lon":392},[396,399],{"name":397,"role":31,"phone":33,"phoneExt":33,"email":398},"Rhea Robinson, RN","rmrobinson@ascension.org",{"name":400,"role":56,"phone":33,"phoneExt":33,"email":33},"Virginia Harrod",{"facility":402,"status":38,"city":403,"state":404,"zip":405,"country":406,"countryCode":407,"cosmosGeoPoint":408,"geoPoint":412,"contacts":413},"CHUQ","Québec","Quebec","QC G1V 4W6","Canada","CA",{"type":45,"coordinates":409},[410,411],-71.21454,46.81228,{"lat":411,"lon":410},[414,417],{"name":415,"role":31,"phone":33,"phoneExt":33,"email":416},"Valérie-Ève Julien","Valerie-Eve.Julien@crchudequebec.ulaval.ca",{"name":418,"role":56,"phone":33,"phoneExt":33,"email":33},"Bruno Michon",{"type":420,"investigatorFullName":421,"investigatorTitle":422,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","Giselle Sholler","Beat Childhood Cancer Chair","100415929","phase-2-dfmo-as-maintenance-therapy-for-molecular-highvery-high-risk-and-relapsed-medulloblastoma-100415929",false,"NCT04696029","DFMO as Maintenance Therapy for Molecular High\u002FVery High Risk and Relapsed Medulloblastoma","Phase II Trial of Eflornithine\u002FDFMO as Maintenance Therapy for Molecular High Risk\u002FVery High Risk and Relapsed\u002FRefractory Medulloblastoma","Inclusion Criteria:\n\n1. Age: 0-21 years of age at diagnosis\n2. Pathology All patients must either have a pathologically confirmed diagnosis of medulloblastoma with molecular grouping identified by either Nanostring or methylation profiling.\n\n   Cohort 1- Molecular High Risk:\n   * Metastatic non-MYC amplified Group 3\n   * Metastatic Group 4\n   * Metastatic non-WNT\u002Fnon-SHH (Must be non-MYC amplified)\n\n   Cohort 2- Molecular Very High Risk\n   * Metastatic OR MYCN amplified OR TP53 mutant non-infant (\\>3 yrs) SHH\n   * MYC amplified Group 3\n   * Non-WNT, non-SHH infant (\\\u003C 3 yrs)\n\n   Cohort 3: Relapsed\u002FRefractory Medulloblastoma\n3. Pre-enrollment tumor survey:\n\n   Prior to enrollment on this study, a determination of mandatory disease staging must be performed:\n   * Tumor imaging studies including: Brain and spine MRI\n   * Lumbar Puncture only if previously positive\n   * Bone Marrow aspiration\u002Fbiopsy only if previously positive\n   * This disease assessment is required for eligibility and preferably should be done within 2 weeks prior to first dose of study drug, but must be done within a maximum of 4 weeks before first dose of study drug.\n4. Disease Status: Subjects must have no evidence of disease, or stable\\* residual nonbulky\\*\\* disease.\n\n   \\*Stable residual disease defined as non-progression over 2 separate imaging studies at least 6 weeks apart\n\n   \\*\\*Non-bulky disease defined as maximal cross-sectional area \\\u003C 3cm\\^2 at enrollment. Patients with leptomeningeal disease are allowed to participate on study.\n5. Timing from prior therapy:\n\n   Enrollment (first dose of DFMO) no later than 60 days after last dose of conventional chemotherapy. Patients who have undergone high dose chemotherapy (HDCT) with autologous stem cell transplantation (SCT) are eligible if more than 45 days have elapsed since date of last SCT.\n6. Patients must have a Lansky or Karnofsky Performance Scale score of ≥ 50% (see Appendix II) and patients must have a life expectancy of ≥ 2 months.\n7. All clinical and laboratory studies for organ functions to determine eligibility must be performed within 7 days prior to first dose of study drug unless otherwise indicated below.\n8. Patients must have adequate organ functions at the time of registration:\n\n   * Hematological: Hematological recovery as defined by ANC ≥750\u002FμL, platelets ≥30 (non-transfused x 7 days)\n   * Liver: Adequate liver function as defined by AST and ALT \\\u003C10x upper limit of normal\n   * Renal: Adequate renal function defined as (perform one of the following): Creatinine clearance or radioisotope GFR ≥ 70 mL\u002Fmin\u002F1.73 m2 or a serum creatinine based on age\u002Fgender\n9. Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.\n10. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all subjects (or patients' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Metastatic disease outside of CNS\n3. Relapsed\u002Frefractory patients who are radiation-naïve and age 5 years or older at time of enrollment\n4. Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.\n5. Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.\n6. Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n7. Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.","ALL","21 Years",{"count":433,"type":434},118,"ESTIMATED","INTERVENTIONAL",[437],"PHASE2","Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study as Maintenance Therapy for Molecular High Risk\u002FVery High Risk and Relapsed\u002FRefractory Medulloblastoma.",[440],"Medulloblastoma","2026-04-24",{"date":443,"type":444},"2026-04-28","ACTUAL",{"date":446,"type":444},"2021-03-29",{"date":448,"type":434},"2029-03",{"name":421,"class":6},24]