Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission

ClinicalTrials.gov ID: NCT02395666

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Official title

A Phase II Preventative Trial of DFMO (Eflornithine HCl) as a Single Agent in Patients With High Risk Neuroblastoma in Remission

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this research study is to evaluate a new investigational drug to prevent reoccurrence of neuroblastoma that is in remission. This study drug is called DFMO. The objectives of this study will be to monitor for safety and look at efficacy of DFMO. The safety of the proposed dosing regimen in this trial will be tested by an on-going risk/benefit assessment during the study. A patient benefiting from treatment, not progressing on therapy, and in the absence of any safety issues associated with DFMO may continue on treatment up to 27 cycles with the expectation that there will be an overall clinical benefit. The procedures involved in this study include Medical history, Physical exam, Vital signs (blood pressure, pulse, temperature), Blood tests, Urine tests, MRI or CT scan of the tumor(s), meta-iodobenzylguanidine (MIBG) scans, and Bone marrow aspirations. All of these tests and procedures are considered standard of care for this population. Drug administration is also part of this protocol, including an investigational new drug called DFMO. The proposed dosing regimen is an oral dose of DFMO tablets two times a day for each day while on study. There will be 27 cycles. Each cycle will be 28 days in length.

Study identification

NCT ID: NCT02395666
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Giselle Sholler; Other
Enrollment: 140 participants

Conditions and interventions

Conditions

Neuroblastoma

Interventions

DFMO Drug

Drug

Eligibility (public fields only)

Age range: Up to 21 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 5, 2015 (Actual)
Primary completion: Mar 27, 2018 (Actual)
Completion: Aug 24, 2023 (Actual)
Last update posted: Aug 6, 2024

2015 – 2023

United States locations

U.S. sites: 22
U.S. states: 18
U.S. cities: 22

Facility	City	State	ZIP	Site status
Phoenix Children's Hospital	Phoenix	Arizona	85016	—
Arkansas Children's Hospital	Little Rock	Arkansas	72202	—
Rady Children's Hospital	San Diego	California	92123	—
Connecticut Children's Hospital	Hartford	Connecticut	06106	—
Arnold Palmer Hospital for Children	Orlando	Florida	32806	—
All Children's Hospital Johns Hopkins Medicine	St. Petersburg	Florida	33701	—
Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	96813	—
Tufts Medical Center	Boston	Massachusetts	02111	—
Helen DeVos Children's Hospital	Grand Rapids	Michigan	49503	—
Children's Hospital and Clinics on Minnesota	Minneapolis	Minnesota	55404	—
Children's Mercy Hospitals and Clinics	Kansas City	Missouri	64108	—
Cardinal Glennon Children's Medical Center	St Louis	Missouri	63104	—
The Children's Hospital at Montefiore	The Bronx	New York	10467	—
Levine Children's Hospital	Charlotte	North Carolina	28204	—
Nationwide Children's Hospital	Columbus	Ohio	43205	—
Penn State Milton S. Hershey Medical Center and Children's Hospital	Hershey	Pennsylvania	17033	—
Medical University of South Carolina	Charleston	South Carolina	29425	—
Monroe Carrell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee	37232	—
Dell Children's Blood and Cancer Center	Austin	Texas	78723	—
Children's Medical Center	Dallas	Texas	75235	—
Texas Children's Cancer and Hematology Centers	Houston	Texas	77030	—
Primary Children's Hospital	Salt Lake City	Utah	84113	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02395666, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 6, 2024 · Synced Nov 15, 2026