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Spots Global Cancer Trial Database for DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma

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We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: Phase II Trial of Eflornithine/DFMO as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma

Study ID: NCT04696029

Conditions

Medulloblastoma

Study Description

Brief Summary: 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.

Detailed Description: In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 2500 mg/m2 BID on each day of study. Subjects will be evaluated in 3 Cohorts: Cohort 1: Molecular High Risk Medulloblastoma Cohort 2: Molecular Very High Risk Medulloblastoma Cohort 3: Relapsed/Refractory Medulloblastoma A total of 118 subjects across all cohorts will be enrolled to ensure that there will be 107 evaluable subjects (32-39 per cohort)

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Arkansas Children's Hospital, Little Rock, Arkansas, United States

UCSF Benioff Children's Hospital Oakland-, Oakland, California, United States

Rady Children's Hospital, San Diego, California, United States

Connecticut Children's Hospital, Hartford, Connecticut, United States

Arnold Palmer Hospital for Children, Orlando, Florida, United States

St. Joseph's Children's Hospital, Tampa, Florida, United States

Kentucky Children's Hospital, Lexington, Kentucky, United States

University of Louisville/Norton's Children's, Louisville, Kentucky, United States

Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States

Cardinal Glennon Children's Medical Center, Saint Louis, Missouri, United States

Hackensack University Medical Center, Hackensack, New Jersey, United States

Levine Children's Hospital, Charlotte, North Carolina, United States

Penn State Milton S. Hershey Medical Center and Children's Hospital, Hershey, Pennsylvania, United States

Medical University of South Carolina, Charleston, South Carolina, United States

Dell Children's Blood and Cancer Center, Austin, Texas, United States

Contact Details

Name: Michael A Huang, MD

Affiliation: Beat Childhood Cancer at Atrium Health

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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