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Monoclonal Antibodies

Combination Chemotherapy for Neuroblastoma

Phase 2
Waitlist Available
Led By Margaret E Macy
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines (i.e. > 2 x upper limit of normal [ULN]) at initial diagnosis
First episode of progressive high-risk disease during aggressive multi-drug frontline therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat neuroblastoma that has returned or is unresponsive to treatment. The drugs work in different ways to stop the growth of cancer cells.

Who is the study for?
This trial is for patients with high-risk neuroblastoma that's either come back or isn't responding to treatment. They should have measurable tumor growth, more than 5% bone marrow disease involvement, and a performance status of ECOG 0-2. Patients must not have received certain prior treatments like long-acting myeloid growth factors within specific time frames and must meet various health criteria including adequate organ function.Check my eligibility
What is being tested?
The trial tests if combining chemotherapy drugs irinotecan hydrochloride and temozolomide with the immunotherapy drug dinutuximab improves when adding eflornithine in patients with relapsed or refractory neuroblastoma. It aims to see whether this combination can better stop cancer cells from growing by killing them, stopping their division, or preventing their spread.See study design
What are the potential side effects?
Possible side effects include reactions related to chemotherapy such as nausea, vomiting, diarrhea, low blood counts leading to increased infection risk; allergic reactions due to dinutuximab; and potential unknown risks associated with eflornithine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed as neuroblastoma or ganglioneuroblastoma with high urinary catecholamines.
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My condition worsened for the first time despite strong initial treatment.
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My scan shows active cancer that has returned or is not responding to treatment.
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I have no active brain or spinal cord disease.
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I can care for myself but may not be able to do active work.
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I've had 4+ cycles of initial chemo for high-risk cancer but no second-line treatment for relapse.
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My neuroblastoma did not respond well to initial intense chemotherapy.
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I have a tumor visible on scans or confirmed neuroblastoma in my bone marrow.
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My tumor is visible and measurable on a scan.
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It's been over 21 days since my last antibody treatment and any side effects are mild.
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I don't have trouble breathing at rest, can exercise, don't need oxygen, and my oxygen levels are good.
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I haven't taken any cancer medication that lowers blood counts in the last 7 days.
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My cancer was confirmed through tests and I have high levels of certain chemicals in my urine.
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My bone marrow disease involves more than 5% neuroblastoma cells.
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I can take care of myself but may not be able to do active work.
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My high-risk disease has returned after I completed an intense treatment.
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It has been over 2 weeks since my last treatment that lowers my blood cell counts.
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My kidney function is within the required range for my age and gender.
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My liver enzyme (ALT) levels are within the normal range for my age.
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I am receiving a strong chemotherapy that includes drugs from two specific classes.
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I have had a stem cell infusion treated with a special process.
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My brain-related side effects are mild.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response rate
Secondary outcome measures
Incidence of adverse events >= Grade 3 (Regimen B)
Overall survival (OS)
Progression-free survival (PFS)
Other outcome measures
GD2 levels in tumor cells from bone marrow samples
Immune and cytokine profiles
Patient reported pain and opiate usage

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Regimen B (eflornithine, chemotherapy, dinutuximab)Experimental Treatment5 Interventions
Patients receive eflornithine PO, via NG, or G tube on days -6 to 7 and days 15-21 of cycle 1 and days 1-7 and 15-21 of subsequent cycles, temozolomide PO, via NG, or G tube on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Treatment duration is 28 days for cycle 1 and then every 21 days in subsequent cycles for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Regimen A (chemotherapy, dinutuximab, sargramostim)Active Control4 Interventions
Patients receive temozolomide PO, via NG, or G tube on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12 of a 21-day cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Sargramostim
2008
Completed Phase 4
~710
Temozolomide
2010
Completed Phase 3
~1930
Dinutuximab
2009
Completed Phase 3
~710

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
454 Previous Clinical Trials
237,845 Total Patients Enrolled
63 Trials studying Neuroblastoma
31,774 Patients Enrolled for Neuroblastoma
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,392 Total Patients Enrolled
205 Trials studying Neuroblastoma
53,633 Patients Enrolled for Neuroblastoma
Margaret E MacyPrincipal InvestigatorChildren's Oncology Group

Media Library

Dinutuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03794349 — Phase 2
Neuroblastoma Research Study Groups: Regimen A (chemotherapy, dinutuximab, sargramostim), Regimen B (eflornithine, chemotherapy, dinutuximab)
Neuroblastoma Clinical Trial 2023: Dinutuximab Highlights & Side Effects. Trial Name: NCT03794349 — Phase 2
Dinutuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03794349 — Phase 2

Frequently Asked Questions

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

Is access to this experiment currently available for participants?

"According to the information posted on clinicaltrials.gov, this ongoing trial is presently in search of participants. It was first advertised on May 28th 2019 and had its latest update occur on November 28th 2022."

Answered by AI

Has Dinutuximab received any official sanction from the FDA?

"With Phase 2 clinical trials providing evidence of safety, Dinutuximab received a rating of two on our team's scale. However, efficacy data is still lacking for this drug."

Answered by AI

What is the enrollment capacity of this research venture?

"This medical trial requires 95 eligible candidates to partake in it. Participants can come from The Montreal Children's Hospital of the MUHC and IWK Health Centre, which are located in Montreal, Quebec and Halifax, Nova Scotia respectively."

Answered by AI

Has Dinutuximab been the subject of any other scientific investigations?

"Currently, 498 clinical trials researching Dinutuximab are in progress. Of the 85 Phase 3 studies conducted on this drug, most of them take place in Woolloongabba, Queensland but there is a global reach with 15872 locations hosting these medical experiments."

Answered by AI

Are there a multitude of research centers executing this study in Canada?

"This trial is being conducted at The Montreal Children's Hospital of the MUHC in Quebec, IWK Health Centre in Halifax, Nova Scotia and Children's Hospitals and Clinics of Minnesota - Minneapolis in Minneapolis. Furthermore, there are 100 other participating medical sites around North America."

Answered by AI

What conditions have been successfully managed with Dinutuximab?

"Dinutuximab can be utilized to treat esophageal neoplasms malignant, acute lymphoblastic leukemia (ALL), and melanoma."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Cook Children's Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma
2019. "Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03794349.
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~15 spots leftby Mar 2025
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