Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission
Public ClinicalTrials.gov record NCT02395666. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
- Enrollment
- 140 participants
Conditions and interventions
Conditions
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 4, 2015
- Primary completion
- Mar 26, 2018
- Completion
- Aug 23, 2023
- Last update posted
- Aug 5, 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 5, 2024 · Synced Sep 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02395666 live on ClinicalTrials.gov.