Actively Recruiting
Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
Led by Giselle Sholler · Updated on 2026-04-28
500
Participants Needed
28
Research Sites
1043 weeks
Total Duration
On this page
Sponsors
G
Giselle Sholler
Lead Sponsor
D
Dell, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A prospective open label, multicenter study to evaluate the feasibility and acute toxicity of using molecularly guided therapy in combination with standard therapy followed by a Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma.
CONDITIONS
Official Title
Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of neuroblastoma or ganglioneuroblastoma confirmed by histology or bone marrow tests
- Newly diagnosed neuroblastoma with INSS Stage 4, age > 18 months regardless of biology, or age 12-18 months with unfavorable features, or MYCN amplification
- Newly diagnosed neuroblastoma with INSS Stage 3 with MYCN amplification or age > 18 months with unfavorable pathology
- Newly diagnosed neuroblastoma with INSS Stage 2A/2B with MYCN amplification
- Age 21 years or younger at initial diagnosis
- No prior systemic therapy except limited emergency radiation or one cycle of low/intermediate risk chemotherapy
- Ability to tolerate peripheral blood stem cell collection
- Adequate cardiac function (shortening fraction ≥ 27% or ejection fraction ≥ 50%)
- Adequate liver function (total bilirubin ≤ 1.5 x ULN and ALT < 10 x ULN)
- Adequate renal function based on age and gender serum creatinine limits
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective birth control methods during treatment and six months after
- Signed informed consent and assent as appropriate
- For Part B, pathological diagnosis of neuroblastoma, age ≤ 21, classified as high risk, and meeting staging and timing requirements
You will not qualify if you...
- Subjects 12-18 months old with INSS Stage 4 and all Stage 3 subjects with favorable biology are not eligible
- Lactating females unless agreeing not to breastfeed
- Receiving any other investigational drug concurrently
- Presence of other medical conditions like malabsorption syndromes, mental illness, or substance abuse that interfere with consent or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 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
Connecticut Children's Hospital
Hartford, Connecticut, United States, 06106
Actively Recruiting
6
Nicklaus Children's Miami
Miami, Florida, United States, 33155
Actively Recruiting
7
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
8
St. Joseph's Children's Hospital
Tampa, Florida, United States, 33614
Actively Recruiting
9
Augusta University Health
Augusta, Georgia, United States, 30912
Actively Recruiting
10
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96813
Actively Recruiting
11
St. Lukes
Boise, Idaho, United States, 83712
Completed
12
Advocate Aurora Research Institute
Chicago, Illinois, United States, 60453
Completed
13
Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine
Louisville, Kentucky, United States, 40202
Actively Recruiting
14
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
15
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
16
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Completed
17
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States, 63104
Actively Recruiting
18
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Completed
19
Levine Children's Hospital
Charlotte, North Carolina, United States, 28204
Actively Recruiting
20
Randall Children's Hospital
Portland, Oregon, United States, 97227
Actively Recruiting
21
Penn State Milton S. Hershey Medical Center and Children's Hospital
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
22
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
23
Dell Children's Blood and Cancer Center
Austin, Texas, United States, 78723
Actively Recruiting
24
Children's Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
25
Alberta Children's Hospital
Calgary, Alberta, Canada, AB T3B 6A8
Actively Recruiting
26
CHU Sainte-Justine
Montreal, Quebec, Canada, QC H3S 2G4
Actively Recruiting
27
CHUQ
Québec, Quebec, Canada, QC G1V 4W6
Actively Recruiting
28
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
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here