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NCT02395666 · ClinicalTrials.gov registry record · Phase 2
Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission
A Phase 2 study of Neuroblastoma, sponsored by Giselle Sholler.
- Completed
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 20
- Study locations
NCT02395666: Completed Phase 2 study of Neuroblastoma, sponsored by Giselle Sholler.
NCT02395666 is a Phase 2 study of Neuroblastoma that has completed, run by Giselle Sholler. The registered enrollment target is 140 participants, below the 237-participant average among 94 other Neuroblastoma trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02395666, a Phase 2 study of Neuroblastoma, has completed, sponsored by Giselle Sholler.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
To evaluate the preventative activity of DFMO as a single agent in patients that are in remission based on: Event free survival (EFS)
Conditions Studied
Interventions
- DRUG DFMO
Study Locations (20)
Florida
- Arnold Palmer Hospital for Children - Orlando
- All Children's Hospital Johns Hopkins Medicine - St. Petersburg
Missouri
- Children's Mercy Hospitals and Clinics - Kansas City
- Cardinal Glennon Children's Medical Center - St Louis
Texas
- Dell Children's Blood and Cancer Center - Austin
- Children's Medical Center - Dallas
Arizona
- Phoenix Children's Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
California
- Rady Children's Hospital - San Diego
Connecticut
- Connecticut Children's Hospital - Hartford
Hawaii
- Kapiolani Medical Center for Women and Children - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2015-03-05 |
| Est. Completion | 2023-08-24 |
| Phase | Phase 2 |
What the finished NCT02395666 record still lists
NCT02395666 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 237-participant average among 94 other Neuroblastoma trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 1 intervention - of which DFMO is the first listed.
NCT02395666 names 20 study sites across 17 states, led by Florida, Missouri, Texas.
Frequently Asked Questions
What is clinical trial NCT02395666 about?
NCT02395666 is a clinical study titled "Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission". 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 regi...
What is the current status of trial NCT02395666?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2015-03-05. Estimated completion is 2023-08-24.
What conditions does trial NCT02395666 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT02395666?
The interventions under investigation include: DFMO (DRUG).
Who is sponsoring clinical trial NCT02395666?
This trial is sponsored by Giselle Sholler, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02395666 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02395666's enrollment target sits among peer trials
140 22nd of 94 higher than 73 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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