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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02395666
The ClinicalTrials.gov registry entry for NCT02395666 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 237-participant average among 94 other Neuroblastoma trials with a reported enrollment target (41% lower). The listed sponsor is Giselle Sholler, which has 20 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 17 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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