Actively Recruiting
Neuroblastoma Maintenance Therapy Trial
Led by Giselle Sholler · Updated on 2026-01-21
441
Participants Needed
49
Research Sites
887 weeks
Total Duration
On this page
Sponsors
G
Giselle Sholler
Lead Sponsor
B
Beat NB Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter, study for patients with neuroblastoma in remission. In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2, 3, and 4) OR 2500 mg/m2 BID (stratum 1B) on each day of study. This study will focus on the use of DFMO in high risk neuroblastoma patients that are in remission as a strategy to prevent recurrence.
CONDITIONS
Official Title
Neuroblastoma Maintenance Therapy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a confirmed diagnosis of neuroblastoma and be younger than 31 years old
- Patients must be classified as high risk at diagnosis or have converted to high risk after relapse
- Patients must be in complete remission with no evidence of disease on scans or bone marrow
- Patients in Stratum 1/1B must have completed standard upfront therapy including chemotherapy, surgery if feasible, stem cell transplant, radiotherapy, and immunotherapy with dinutuximab and retinoic acid
- Patients in Stratum 1/1B must have met response criteria including less than 10% tumor involvement in bone marrow before transplant
- Patients in Stratum 2 must be in first complete remission following standard therapy different from Stratum 1
- Patients in Stratum 3 must have achieved complete remission after failing to respond to induction chemotherapy and surgery but responding to additional therapy
- Patients in Stratum 4 must have achieved a second or subsequent complete remission after relapse
- Pre-enrollment tumor survey including imaging and bilateral bone marrow aspirates and biopsy must be completed within 4 weeks before enrollment
- Patients must enroll no later than 60 days after completing prior therapy
- Patients must have a Lansky or Karnofsky score over 50% and life expectancy of at least 2 months
- Organ function tests must be done within 7 days before enrollment showing adequate hematological, liver, and kidney function
- Females of childbearing potential must have a negative pregnancy test and agree to use birth control; lactating females must agree to stop breastfeeding
- Written informed consent must be obtained
You will not qualify if you...
- Body surface area less than 0.25 m2
- Currently receiving investigational drugs
- Currently receiving other anticancer agents or not recovered from prior chemotherapy effects
- Uncontrolled infection until judged well controlled by investigator
- Inability to comply with study safety monitoring or likely poor compliance according to investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 49 locations
1
University of Alabama, Children's of Alabama
Birmingham, Alabama, United States, 35233
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
Rocky Mountain Pediatric Hematology
Denver, Colorado, United States, 80205
Actively Recruiting
6
Connecticut Children's Hospital
Hartford, Connecticut, United States, 06106
Actively Recruiting
7
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
8
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
9
All Children's Hospital Johns Hopkins Medicine
St. Petersburg, Florida, United States, 33701
Actively Recruiting
10
St. Joseph's Children's Hospital
Tampa, Florida, United States, 33614
Actively Recruiting
11
Augusta University Health
Augusta, Georgia, United States, 30912
Actively Recruiting
12
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96813
Actively Recruiting
13
St. Lukes
Boise, Idaho, United States, 83712
Completed
14
Advocate Aurora Research Institute
Chicago, Illinois, United States, 60453
Actively Recruiting
15
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
16
Kentucky Children's Hospital
Lexington, Kentucky, United States, 40536
Actively Recruiting
17
Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine
Louisville, Kentucky, United States, 40202
Actively Recruiting
18
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Completed
19
University of Massachusetts Medical School Worcester
Worcester, Massachusetts, United States, 01655
Withdrawn
20
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
21
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
22
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
23
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States, 63104
Actively Recruiting
24
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
25
NYU Langone Health Hassenfeld Children's Hospital
New York, New York, United States, 10016
Actively Recruiting
26
The Children's Hospital at Montefiore
The Bronx, New York, United States, 10467
Completed
27
Levine Children's Hospital
Charlotte, North Carolina, United States, 28204
Actively Recruiting
28
Duke University
Durham, North Carolina, United States, 27708
Actively Recruiting
29
Cleveland Clinic Children's
Cleveland, Ohio, United States, 44106
Actively Recruiting
30
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Active, Not Recruiting
31
Randall Children's Hospital
Portland, Oregon, United States, 97227
Actively Recruiting
32
Penn State Milton S. Hershey Medical Center and Children's Hospital
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
33
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
34
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
35
Monroe Carrell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Actively Recruiting
36
Dell Children's Blood and Cancer Center
Austin, Texas, United States, 78723
Actively Recruiting
37
Children's Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
38
Texas Children's Cancer and Hematology Centers
Houston, Texas, United States, 77030
Active, Not Recruiting
39
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
40
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
41
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Actively Recruiting
42
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
43
Alberta Children's Hospital
Calgary, Alberta, Canada, AB T3B 6A8
Actively Recruiting
44
CancerCare Manitoba
Winnipeg, Manitoba, Canada, MB R3E 0V9
Actively Recruiting
45
Janesway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada, NL A1B 3V6
Actively Recruiting
46
UHC Sainte-Justine
Montreal, Quebec, Canada, QC H3S 2G4
Actively Recruiting
47
Montreal Children's Hospital
Montreal, Quebec, Canada, QC H4A 3H9
Actively Recruiting
48
CHUQ
Québec, Quebec, Canada, QC G1V 4W6
Actively Recruiting
49
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
PREVENTION
Number of Arms
1
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