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ALK Inhibitor

Advanced Therapy for Neuroblastoma (PEDS-PLAN Trial)

Phase 2
Recruiting
Research Sponsored by Giselle Sholler
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have a diagnosis of neuroblastoma or ganglioneuroblastoma verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
Subjects must be age ≤ 21 years at initial diagnosis
Must not have
Subjects who are 12-18 months of age with INSS Stage 4 and all stage 3 subjects with favorable biologic features are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years plus 5 years follow up
Awards & highlights

Summary

This trial is testing whether adding a new drug to standard treatment for neuroblastoma is safe and effective.

Who is the study for?
This trial is for children and young adults up to 21 years old with high-risk neuroblastoma. Participants must have proper heart, liver, and kidney function, not have had more than one cycle of certain chemotherapies, and be able to undergo stem cell collection. Pregnant or breastfeeding individuals can't join; neither can those with conditions that might affect the study's results.
What is being tested?
The study tests molecularly guided therapy combined with standard treatments for neuroblastoma. It includes a randomized trial comparing standard immunotherapy alone versus with DFMO (an investigational drug), followed by maintenance therapy using DFMO.
What are the potential side effects?
Possible side effects may include digestive issues, blood disorders, fatigue, allergic reactions to drugs like DFMO or vorinostat, and potential complications from procedures like stem cell collection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with neuroblastoma or ganglioneuroblastoma.
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I was 21 years old or younger when first diagnosed.
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My liver tests are within the required range.
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I can safely undergo a stem cell collection procedure.
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My kidney function is good based on my age and gender.
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My heart is strong, with a good pumping efficiency.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not between 12-18 months old with specific advanced neuroblastoma stages.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years plus 5 years follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years plus 5 years follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of days from start of therapy to date of first relapse
Therapeutic procedure
Number of subjects that receive 75% of dosing of medications while on study protocol during cycles 3-6.
Secondary study objectives
Analgesics
Number of days that subjects remain alive
Therapeutic procedure
+2 more

Trial Design

2Treatment groups
Active Control
Group I: Standard Immunotherapy without DFMOActive Control4 Interventions
One of the following drugs will be chosen for each subject based on molecular guided results: ceritinib, dasatinib, sorafenib or vorinostat. This will be followed standard immunotherapy with Dinutuximab/GM-CSF/IL-2 and isotretinoin. At the end of immunotherapy, DFMO will be given to all subjects BID for 730 days.
Group II: Standard Immunotherapy with DFMOActive Control5 Interventions
One of the following drugs will be chosen for each subject based on molecular guided results: ceritinib, dasatinib, sorafenib or vorinostat. This will be followed standard immunotherapy with Dinutuximab/GM-CSF/IL-2 and isotretinoin PLUS 1000mg/m2 BID of DFMO. At the end of immunotherapy, all subjects will go on to receive DFMO BID for 730 days.

Find a Location

Who is running the clinical trial?

Beat NB Cancer FoundationOTHER
5 Previous Clinical Trials
634 Total Patients Enrolled
5 Trials studying Neuroblastoma
634 Patients Enrolled for Neuroblastoma
K C Pharmaceuticals Inc.Industry Sponsor
4 Previous Clinical Trials
287 Total Patients Enrolled
4 Trials studying Neuroblastoma
287 Patients Enrolled for Neuroblastoma
Team Parker for LifeUNKNOWN
2 Previous Clinical Trials
389 Total Patients Enrolled
2 Trials studying Neuroblastoma
389 Patients Enrolled for Neuroblastoma

Media Library

Ceritinib (ALK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02559778 — Phase 2
Neuroblastoma Research Study Groups: Standard Immunotherapy without DFMO, Standard Immunotherapy with DFMO
Neuroblastoma Clinical Trial 2023: Ceritinib Highlights & Side Effects. Trial Name: NCT02559778 — Phase 2
~197 spots leftby Sep 2030
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