Actively Recruiting
Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
Led by Giselle Sholler · Updated on 2026-02-03
131
Participants Needed
31
Research Sites
679 weeks
Total Duration
On this page
Sponsors
G
Giselle Sholler
Lead Sponsor
K
K C Pharmaceuticals Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study in combination with etoposide for subjects with relapsed/refractory neuroblastoma.
CONDITIONS
Official Title
Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a confirmed diagnosis of neuroblastoma and be 30.99 years old or younger with relapsed or refractory disease.
- Patients must have completed at least 4 cycles of aggressive multi-drug chemotherapy.
- For Arms 1 and 2: No active disease shown by CT/MRI and MIBG or PET scans, and no evidence of bone marrow metastasis.
- Enrollment must occur within 60 days of last therapy dose.
- Patients must have recovered from prior treatments according to specified timelines for chemotherapy, growth factors, biologic agents, immunotherapy, monoclonal antibodies, radiation, stem cell transplant, and MIBG therapy.
- Lansky or Karnofsky Performance Scale score of 60% or higher.
- Life expectancy greater than 2 months.
- Adequate organ function confirmed within 7 days before first dose.
- Negative pregnancy test and agreement to use birth control if of childbearing potential; breastfeeding must stop.
- Written informed consent must be obtained.
You will not qualify if you...
- Body surface area less than 0.25 m2.
- Prior use of DFMO at doses higher than 1000 mg/m2 twice daily.
- Prior treatment with DFMO combined with etoposide.
- Currently receiving another investigational drug.
- Currently receiving other anticancer agents or not fully recovered from prior chemotherapy effects.
- Uncontrolled infections.
- Inability or unlikely compliance with safety monitoring requirements as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
University of Alabama/Children's of Alabama
Birmingham, Alabama, United States, 35201
Actively Recruiting
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
4
Rady Children's Hospital
San Diego, California, United States, 92123
Actively Recruiting
5
Connecticut Children's Hospital
Hartford, Connecticut, United States, 06106
Actively Recruiting
6
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
7
St. Joseph's Children's Hospital
Tampa, Florida, United States, 33614
Actively Recruiting
8
Augusta University Health
Augusta, Georgia, United States, 30912
Actively Recruiting
9
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
10
Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine
Louisville, Kentucky, United States, 40201
Actively Recruiting
11
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
12
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
13
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
14
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States, 63104
Actively Recruiting
15
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
16
Levine Children's Hospital
Charlotte, North Carolina, United States, 28204
Actively Recruiting
17
Cleveland Clinic Children's
Cleveland, Ohio, United States, 44195
Actively Recruiting
18
Randall Children's Hospital
Portland, Oregon, United States, 97227
Actively Recruiting
19
Penn State Milton S. Hershey Medical Center and Children's Hospital
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
20
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02901
Actively Recruiting
21
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
22
Dell Children's Blood and Cancer Center
Austin, Texas, United States, 78723
Actively Recruiting
23
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
Actively Recruiting
24
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
25
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
26
Alberta Children's Hospital
Calgary, Alberta, Canada, AB T3B 6A8
Actively Recruiting
27
CancerCare Manitoba
Winnipeg, Manitoba, Canada, MB R3E 0V9
Actively Recruiting
28
UHC Sainte-Justine
Montreal, Quebec, Canada, QC H3S 2G4
Actively Recruiting
29
Montreal Children's Hospital
Montreal, Quebec, Canada, QC H4A 3H9
Actively Recruiting
30
CHUQ
Québec, Quebec, Canada, QC G1V 4W6
Actively Recruiting
31
CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, Canada, QC J1H 5H3
Actively Recruiting
Research Team
B
BCC Enroll
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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