RecruitingPhase 2NCT02679144

Neuroblastoma Maintenance Therapy Trial

NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

Sponsor

Giselle Sholler

Enrollment

441 participants

Start Date

Feb 1, 2016

Study Type

INTERVENTIONAL

Conditions

Neuroblastoma

Summary

Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter, study for patients with neuroblastoma in remission. In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2, 3, and 4) OR 2500 mg/m2 BID (stratum 1B) on each day of study. This study will focus on the use of DFMO in high risk neuroblastoma patients that are in remission as a strategy to prevent recurrence.

Eligibility

Min Age: 1 YearMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing maintenance therapy for neuroblastoma (a cancer that commonly affects young children, often starting in the adrenal glands or abdomen) after initial treatment, to help prevent the cancer from coming back. **You may be eligible if...** - Your child has been diagnosed with high-risk neuroblastoma - Your child has completed initial treatment (surgery, chemotherapy, and/or stem cell transplant) and the cancer is in remission or stable - Your child meets the age requirements of the study - Your child is in adequate health to receive maintenance therapy **You may NOT be eligible if...** - The cancer is still actively progressing - Your child has severe organ problems that make maintenance therapy unsafe - Your child has already received the specific maintenance drugs being studied - Genetic or tumor features of the cancer make your child ineligible per protocol 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

DRUGDifluoromethylornithine (DFMO)

Subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2, 3, and 4) OR 2500 mg/m2 BID (stratum 1B) on each day of study.

Locations(49)

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

Rocky Mountain Pediatric Hematology

Denver, Colorado, United States

Connecticut Children's Hospital

Hartford, Connecticut, United States

University of Florida

Gainesville, Florida, United States

Arnold Palmer Hospital for Children

Orlando, Florida, United States

All Children's Hospital Johns Hopkins Medicine

St. Petersburg, Florida, United States

St. Joseph's Children's Hospital

Tampa, Florida, United States

Augusta University Health

Augusta, Georgia, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

St. Lukes

Boise, Idaho, United States

Advocate Aurora Research Institute

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

Kentucky Children's Hospital

Lexington, Kentucky, United States

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

Louisville, Kentucky, United States

Tufts Medical Center

Boston, Massachusetts, United States

University of Massachusetts Medical School Worcester

Worcester, Massachusetts, 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 Medical Center

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

NYU Langone Health Hassenfeld Children's Hospital

New York, New York, United States

The Children's Hospital at Montefiore

The Bronx, New York, United States

Levine Children's Hospital

Charlotte, North Carolina, United States

Duke University

Durham, North Carolina, United States

Cleveland Clinic Children's

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, 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

Monroe Carrell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Dell Children's Blood and Cancer Center

Austin, Texas, United States

Children's Medical Center

Dallas, Texas, United States

Texas Children's Cancer and Hematology Centers

Houston, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Children's Hospital of The King's Daughters

Norfolk, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Alberta Children's Hospital

Calgary, Alberta, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Janesway Children's Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, 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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NCT02679144

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