RecruitingPhase 2NCT04301843

Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Sponsor

Giselle Sholler

Enrollment

131 participants

Start Date

Sep 25, 2020

Study Type

INTERVENTIONAL

Conditions

Neuroblastoma

Summary

Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study in combination with etoposide for subjects with relapsed/refractory neuroblastoma.

Eligibility

Max Age: 31 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of two drugs — eflornithine (DFMO, which blocks a cell growth pathway) and etoposide (a chemotherapy) — can help children and young adults with neuroblastoma (a childhood cancer that starts in nerve tissue) that has relapsed or not responded to prior treatment. **You may be eligible if...** - You are up to 30 years old with a confirmed diagnosis of neuroblastoma - Your neuroblastoma has relapsed or has not responded to treatment - You have completed at least 4 cycles of initial intensive chemotherapy - Depending on which study arm you qualify for, you may have no active disease or may have active disease being treated **You may NOT be eligible if...** - Your neuroblastoma has never been treated with prior chemotherapy - You have untreated or rapidly worsening disease that requires immediate aggressive treatment (for certain arms) - You have significant organ dysfunction that would prevent safe treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEflornithine

DFMO (difluoromethylornithine) will be given at a dose of 1000 mg/m2 BID on each day of study.

Locations(31)

University of Alabama/Children's of Alabama

Birmingham, Alabama, United States

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

Augusta University Health

Augusta, Georgia, United States

University of Iowa

Iowa City, Iowa, United States

Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine

Louisville, Kentucky, United States

Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Children's Hospital and Clinics of Minnesota

Minneapolis, Minnesota, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Levine Children's Hospital

Charlotte, North Carolina, United States

Cleveland Clinic Children's

Cleveland, Ohio, United States

Randall Children's Hospital

Portland, Oregon, United States

Penn State Milton S. Hershey Medical Center and Children's Hospital

Hershey, Pennsylvania, United States

Hasbro Children's Hospital

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Dell Children's Blood and Cancer Center

Austin, Texas, United States

Children's Medical Center Dallas

Dallas, Texas, United States

Children's Hospital of The King's Daughters

Norfolk, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Alberta Children's Hospital

Calgary, Alberta, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

UHC Sainte-Justine

Montreal, Quebec, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

CHUQ

Québec, Quebec, Canada

CIUSSS de l'Estrie-CHUS

Sherbrooke, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT04301843

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