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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years plus 5 years follow up
Awards & highlights

PEDS-PLAN Trial 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.Check my eligibility
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.See study design
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.

PEDS-PLAN Trial 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.

PEDS-PLAN Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Analgesics
Number of days that subjects remain alive
Therapeutic procedure
+2 more

PEDS-PLAN 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Standard Immunotherapy in tandem with DFMO been explored in other research endeavors?

"First trialled in 2004 at the University of Washington Medical Center - Montlake, Standard Immunotherapy with DFMO has had 695 completed clinical trials to date. Currently, 170 medical centres are actively recruiting for new participants; a majority of these locations lie within Kansas City, Missouri."

Answered by AI

How many individuals are currently involved in this investigation?

"To conduct this clinical trial, Dell Inc. is seeking 500 eligible volunteers across two sites located in Kansas City and Birmingham respectively; these are Children's Mercy Hospitals and Clinics (Missouri) and University of Alabama -Children's of Alabama (Alabama)."

Answered by AI

Are there still openings available for participants in this trial?

"Confirmed. The clinicaltrials.gov data reveals that this medical investigation is actively looking for players, with the original posting on 9/1/2015 and most recent edit occurring on 9/26/2022. 500 volunteers are necessary from 24 distinct sites."

Answered by AI

Does the Food and Drug Administration endorse treatment with Standard Immunotherapy plus DFMO?

"There is preliminary evidence affirming the safety of Standard Immunotherapy with DFMO, granting it a score of 2. However, there are no studies that have been conducted to prove its efficacy."

Answered by AI

What objectives is this experiment attempting to fulfill?

"According to Dell, Inc., the sponsor of this study, the primary outcome measure over a two year duration is the interval from initiation of therapy until relapse. Additionally, secondary outcomes include: relative amount of pain medication utilized between arms A and B; overall response rate in patients with measurable disease via CT or MRI imaging/MIBG or PET scans; and number of participants required to terminate treatment due to adverse events as assessed by CTCAE v4.0. Moreover, research feasibility is also being evaluated based on targeted agent identification, dosing compliance during cycles 3-6 and removal from protocol due to drug related toxicity caused by targeted agents."

Answered by AI

What types of conditions can be treated by Standard Immunotherapy with DFMO?

"Three conditions, hemangiosarcoma, progressive and radioiodine-resistant thyroid cancer (dtc), and hCTAGE1 protein can be effectively managed with DFMO Standard Immunotherapy."

Answered by AI

Are there extensive facilities hosting this clinical research in the state?

"The medical trial is accepting patients from 28 different sites, including Children's Mercy Hospitals and Clinics in Kansas City, the University of Alabama, Children's of Alabama in Birmingham, and Rady Children's Hospital San Diego."

Answered by AI

Who else is applying?

What site did they apply to?
Advocate Children's Medical Group
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
Giselle Sholler 2015. "Pediatric Precision Laboratory Advanced Neuroblastoma Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02559778.
All > Minnesota > Paid Studies Arkansas
~211 spots leftby Sep 2030
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