DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Giselle Sholler
Study ID
NCT04696029
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Difluoromethylornithine — DRUG
    DFMO (difluoromethylornithine is an inhibitor of ornithine decarboxylase (ODC) designated chemically as 2-(difluoromethyl)-DL-ornithine monohydrochloride monohydrate. The 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). The tablets are to be stored at room temperature (20-250C).

Study Details

Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma.

Key Dates

Start date
Mar 29, 2021
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
118 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Difluoromethylornithine (DFMO)
    study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 2500 mg/m2 BID on each day of study.

Primary Outcome Measure

Number of participants with event free survival (EFS) during study [ Time Frame: 2 years plus 5 years follow up ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
Arkansas Children's HospitalLittle RockArkansas72202
Kevin Bielamowicz (PRINCIPAL_INVESTIGATOR)
UCSF Benioff Children's Hospital OaklandOaklandCalifornia94609
Group Contact
[email protected]
Caroline Hastings (PRINCIPAL_INVESTIGATOR)
Rady Children's HospitalSan DiegoCalifornia92123
Sarah Hollander
[email protected]
William Roberts (PRINCIPAL_INVESTIGATOR)
Stanford UniversityStanfordCalifornia94305
Stefania U Chirita
[email protected]
Raya Saab (PRINCIPAL_INVESTIGATOR)
Connecticut Children's HospitalHartfordConnecticut06106
Adam Barselau
[email protected]
Michael Isakoff (PRINCIPAL_INVESTIGATOR)
Nicklaus Children's HospitalMiamiFlorida33155
Aixa Guadarrama
[email protected]
Ossama Maher (PRINCIPAL_INVESTIGATOR)
Arnold Palmer Hospital for ChildrenOrlandoFlorida32806
Marie Frankos
[email protected]
Jamie Libes-Bander (PRINCIPAL_INVESTIGATOR)
All Children's Hospital Johns Hopkins MedicineSt. PetersburgFlorida33701
Kevin Samnarine
[email protected]
Jennifer Dean (PRINCIPAL_INVESTIGATOR)
St. Joseph's Children's HospitalTampaFlorida33607
Jennifer Manns
[email protected]
Don Eslin (PRINCIPAL_INVESTIGATOR)
Kapiolani Medical Center for Women and ChildrenHonoluluHawaii96813
Kelley Hutchins (PRINCIPAL_INVESTIGATOR)
Advocate Aurora Research InstituteChicagoIllinois60453
Jennifer Ward
[email protected]
Rebecca McFall (PRINCIPAL_INVESTIGATOR)
Kentucky Children's HospitalLexingtonKentucky40502
Brittany Fuller
[email protected]
Tom Badgett (PRINCIPAL_INVESTIGATOR)
Norton Children's Research Institute/Affiliated with University of Louisville School of MedicineLouisvilleKentucky40202
Jennifer Miller
Mustafa Barbour (PRINCIPAL_INVESTIGATOR)
Children's Mercy Hospitals and ClinicsKansas CityMissouri64108
Nicole Harvey
[email protected]
Kevin Ginn (PRINCIPAL_INVESTIGATOR)
Cardinal Glennon Children's Medical CenterSt LouisMissouri63104
William Ferguson (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Kellie Daniel
[email protected]
Derek Hanson (PRINCIPAL_INVESTIGATOR)
Levine Children's HospitalCharlotteNorth Carolina28204
Jontyce Green
[email protected]
Thomas Russell (PRINCIPAL_INVESTIGATOR)
University of OklahomaOklahoma CityOklahoma73104
Christina Gonzalez
[email protected]
Rene McNall-Knapp (PRINCIPAL_INVESTIGATOR)
Randall Children's HospitalPortlandOregon97227
Jason Glover (PRINCIPAL_INVESTIGATOR)
Penn State Milton S. Hershey Medical Center and Children's HospitalHersheyPennsylvania17033
Penn State Clinical Trials
[email protected]
Valerie Brown (PRINCIPAL_INVESTIGATOR)
Hasbro Children's HospitalProvidenceRhode Island02903
Christopher Bouressa
[email protected]
Bradley DeNardo (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Shanta Salzar, MD
[email protected]
Jaqueline Kraveka (PRINCIPAL_INVESTIGATOR)
Dell Children's Blood and Cancer CenterAustinTexas78723
Rhea Robinson, RN
[email protected]
Virginia Harrod (PRINCIPAL_INVESTIGATOR)

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