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Arm B (Dinutuimab in induction) for Neuroblastoma
Phase 3
Recruiting
Led By Sara M Federico
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible
≤ 30 years at the time of initial diagnosis with high-risk disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 years
Awards & highlights
Study Summary
This trial is testing if adding a monoclonal antibody called dinutuximab to standard treatments like chemotherapy and stem cell transplantation can help treat children with a type of cancer called high risk neuroblast
Who is the study for?
This trial is for children with high-risk neuroblastoma, a type of cancer. It's open to those under 30 at diagnosis and includes various stages of the disease if certain conditions are met, like specific genetic features or prior limited treatment. Participants need a minimum body surface area and must consent to molecular testing.Check my eligibility
What is being tested?
The study tests dinutuximab added to induction chemotherapy, followed by surgery, radiation therapy, stem cell transplantation, and more chemo. Dinutuximab targets cancer cells for immune destruction; other drugs aim to stop cancer growth or spread.See study design
What are the potential side effects?
Possible side effects include reactions from the monoclonal antibody dinutuximab, damage to organs from chemotherapy (like heart or bone marrow), increased risk of infections due to weakened immunity after stem cell transplant, and general side effects such as nausea and hair loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with a high-risk disease before turning 31.
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I haven't had cancer treatment except as allowed in the criteria.
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My neuroblastoma is high risk based on age, stage, and MYCN status.
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My body surface area is at least 0.25 square meters.
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I have been diagnosed with neuroblastoma or ganglioneuroblastoma.
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I received emergency radiation for critical or life-threatening cancer before or right after my diagnosis was confirmed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event free survival (EFS)
Secondary outcome measures
End of induction (EOI) response rate
GD2 expression
Incidence of adverse events
+1 moreOther outcome measures
Adequacy of diagnostic biopsy specimens
Association between tumor and host factors and outcomes
Associations between end of induction (EOI) response and individual response components
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (Dinutuimab in induction)Experimental Treatment24 Interventions
See detailed description
Group II: Arm A (SOC treatment)Active Control25 Interventions
See detailed description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexrazoxane
2016
Completed Phase 2
~80
Dinutuximab
2009
Completed Phase 3
~710
Thiotepa
2008
Completed Phase 3
~2210
Cyclophosphamide
1995
Completed Phase 3
~3770
Radiation Therapy
2017
Completed Phase 3
~7250
Cisplatin
2013
Completed Phase 3
~1940
Topotecan
2017
Completed Phase 3
~2400
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Computed Tomography
2017
Completed Phase 2
~2720
Temozolomide
2010
Completed Phase 3
~1930
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Bone Scan
2015
Completed Phase 2
~50
Vincristine
2003
Completed Phase 4
~2910
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Doxorubicin
2012
Completed Phase 3
~7940
Irinotecan
2017
Completed Phase 4
~2680
Melphalan
2008
Completed Phase 3
~1500
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Isotretinoin
2019
Completed Phase 4
~3520
Biospecimen Collection
2004
Completed Phase 2
~1720
Etoposide
2010
Completed Phase 3
~2440
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,704 Previous Clinical Trials
40,930,964 Total Patients Enrolled
205 Trials studying Neuroblastoma
53,206 Patients Enrolled for Neuroblastoma
Sara M FedericoPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
42 Total Patients Enrolled
1 Trials studying Neuroblastoma
42 Patients Enrolled for Neuroblastoma
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients currently being sought to participate in this clinical trial?
"As per clinicaltrials.gov, this ongoing trial is actively seeking participants. The initial posting was on April 19th, 2024, with the latest update made on April 27th of the same year."
Answered by AI
In how many distinct venues is this investigation currently accessible?
"The ongoing medical study is accepting participants at 8 sites, with locations including Oakland, Baltimore, and Greenville among others. Opting for the site closest to you is advisable to reduce travel obligations in case of enrollment."
Answered by AI
Has the FDA granted approval for Arm B, which involves using Dinutuximab during the initial phase of treatment?
"According to our assessments at Power, the safety rating for Arm B (involving Dinutuximab during induction) is graded as a 3 due to its Phase 3 trial status. This indicates that there exists some evidence backing its effectiveness and numerous rounds of data supporting its safety profile."
Answered by AI
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