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NCT01059071 · ClinicalTrials.gov registry record · Phase 1
Safety Study for Refractory or Relapsed Neuroblastoma With DFMO Alone and in Combination With Etoposide
A Phase 1 study of Neuroblastoma, sponsored by Giselle Sholler.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 7
- Study locations
NCT01059071 is a Phase 1 study of Neuroblastoma that has completed, run by Giselle Sholler. The registered enrollment target is 21 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (91% lower). The trial reports 7 study locations across 7 states.
The verdict
NCT01059071, a Phase 1 study of Neuroblastoma, has completed, sponsored by Giselle Sholler.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this research study is to evaluate a new investigational drug to treat neuroblastoma. This study drug is called DFMO. The objectives of this study will be to monitor for safety and to find a maximum tolerated dose in this population. A secondary objective will be to 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 and/or etoposide may continue on treatment 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), 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, and later combined with an already approved drug, etoposide. The proposed dosing regimen is an oral dose of DFMO two times a day for each day while on study. There will be 5 cycles. Each cycle will be 21 days in length. The first cycle will be DFMO alone. In the second cycle etoposide will be added in and will be given orally once a day for the first 14 days of each cycle (cycles 2-5).
Conditions Studied
Interventions
- DRUG DFMO
- DRUG Etoposide
Study Locations (7)
California
- Children's Hospital of Orange County - Orange
Connecticut
- Connecticut Children's Hospital - Hartford
Florida
- Arnold Palmer Hospital for Children- MD Anderson - Orlando
Michigan
- Helen DeVos Children's Hospital - Grand Rapids
Missouri
- Children's Mercy Hospitals and Clinics - Kansas City
North Carolina
- Levine Children's Hospital - Charlotte
Vermont
- UVM/FAHC - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-02 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01059071
The ClinicalTrials.gov registry entry for NCT01059071 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (91% 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 2 interventions - of which DFMO is the first listed.
NCT01059071 reports 7 study locations spanning 7 distinct geographic areas - top geographies include California, Connecticut, Florida.
Frequently Asked Questions
What is clinical trial NCT01059071 about?
NCT01059071 is a clinical study titled "Safety Study for Refractory or Relapsed Neuroblastoma With DFMO Alone and in Combination With Etoposide". The purpose of this research study is to evaluate a new investigational drug to treat neuroblastoma. This study drug is called DFMO. The objectives of this study will be to monitor for safety and to find a maximum tolerated dose in this population. A secondary objective will be to look at efficacy o...
What is the current status of trial NCT01059071?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2010-02. Estimated completion is 2015-05.
What conditions does trial NCT01059071 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT01059071?
The interventions under investigation include: DFMO (DRUG), Etoposide (DRUG).
Who is sponsoring clinical trial NCT01059071?
This trial is sponsored by Giselle Sholler, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01059071 being conducted?
This trial has 7 study locations across California, Connecticut, Florida, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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