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Monoclonal Antibodies
Chemo-Immunotherapy for High-Risk Neuroblastoma
Phase 2
Waitlist Available
Led By Ami V Desai
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
INRG Stage MS disease with MYCN amplification
MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR Age > 547 days at the time of diagnosis with MYCN non-amplified tumors with unfavorable histology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of start of protocol therapy to death, assessed up to 60 months
Awards & highlights
Study Summary
This trial is testing a new chemo-immunotherapy treatment for high-risk neuroblastoma patients who have not experienced worsening or recurrence of their disease after Consolidation therapy.
Who is the study for?
This trial is for patients with high-risk neuroblastoma who've completed intensive therapy without disease worsening or recurrence. Eligible participants must have finished 4-6 cycles of chemotherapy, meet specific blood count and organ function criteria, and not have had certain prior treatments like 131I-MIBG therapy or single ASCT. Pregnant women, those on immunosuppressants, or with uncontrolled infections cannot join.Check my eligibility
What is being tested?
The study tests if a combination of dinutuximab (immunotherapy), GM-CSF (white blood cell booster), isotretinoin (cell maturation aid) along with irinotecan and temozolomide (chemotherapies) is safe after Consolidation therapy in high-risk neuroblastoma patients. This chemo-immunotherapy aims to improve treatment outcomes compared to standard immunotherapy alone.See study design
What are the potential side effects?
Possible side effects include reactions to the immune-targeting drug dinutuximab, bone marrow suppression from chemotherapies irinotecan and temozolomide, increased risk of infection due to white blood cell changes from GM-CSF, and skin dryness or other retinoid effects from isotretinoin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced with specific genetic changes.
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My cancer has a specific genetic feature (MYCN amplified) or was diagnosed after 18 months with certain unfavorable characteristics.
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I can take care of myself but may not be able to do active work.
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I have completed 4-6 cycles of high-risk chemotherapy.
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I can take care of myself but may not be able to do heavy physical work.
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My liver enzyme (ALT) levels are within the normal range for my age.
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My child has advanced neuroblastoma with specific genetic features.
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I haven't taken any long-acting bone marrow stimulants in the last 14 days.
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My cancer is advanced but not due to MYCN gene changes.
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I have completed a specific intense chemotherapy followed by a stem cell transplant.
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I've completed 4-6 rounds of intense chemotherapy.
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I have not worsened on treatments like dinutuximab.
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I've had 4 or fewer rounds of chemotherapy before my stem cell transplant.
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My cancer is at a specific stage and has a certain genetic feature.
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My total bilirubin levels are within normal range for my age.
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I have not worsened after treatment with dinutuximab or similar drugs.
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My kidney function is normal or near normal.
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My side effects from previous brain treatments are mild.
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I do not have trouble breathing when I am resting.
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My diagnosis is high-risk neuroblastoma or ganglioneuroblastoma.
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I do not have any active brain or spinal cord diseases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time of start of protocol therapy to death, assessed up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of start of protocol therapy to death, assessed up to 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients who complete 5 cycles of dinutuximab + chemotherapy without progressive disease (PD)
Secondary outcome measures
Event-free survival (EFS)
Overall survival (OS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (temozolomide, irinotecan, dinutuximab)Experimental Treatment13 Interventions
Patients receive temozolomide PO or via enteral tube daily and irinotecan IV over 90 minutes daily on days 1-5, dinutuximab IV over 10-20 hours daily on days 2-5, sargramostim SC or IV over 2 hours daily on days 6-12, and isotretinoin PO BID on days 8-21. Patients undergo MUGA during screening. Patients also undergo MRI, or CT, I23I-MIBG, or FDG-PET, BM aspiration, and BM biopsy on study. Treatment repeats every 28 days for up to 5 cycles (up to 6 cycles for isotretinoin only) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Temozolomide
2010
Completed Phase 3
~1930
Biospecimen Collection
2004
Completed Phase 2
~1730
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Irinotecan
2017
Completed Phase 4
~2680
Sargramostim
2008
Completed Phase 4
~710
Dinutuximab
2009
Completed Phase 3
~710
Isotretinoin
2019
Completed Phase 4
~3520
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
454 Previous Clinical Trials
237,906 Total Patients Enrolled
63 Trials studying Neuroblastoma
31,835 Patients Enrolled for Neuroblastoma
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,607 Total Patients Enrolled
205 Trials studying Neuroblastoma
53,694 Patients Enrolled for Neuroblastoma
Ami V DesaiPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is advanced with specific genetic changes.I have received treatment for my condition before.I have completed 4-6 cycles of high-risk chemotherapy.My cancer has a specific genetic feature (MYCN amplified) or was diagnosed after 18 months with certain unfavorable characteristics.I can take care of myself but may not be able to do active work.I've had up to 4 treatments before my stem cell transplant.I had surgery to remove my primary cancer, or was exempt due to specific reasons.I had surgery to remove my cancer as the first step of treatment.I can take care of myself but may not be able to do heavy physical work.I've had more cancer treatment after my high-dose chemo and stem cell transplant.You have had a severe allergic reaction to anti-GD2 antibodies in the past, or had to stop anti-GD2 therapy due to a reaction.I had one high-dose chemotherapy session with stem cell transplant.I experience symptoms of heart failure.I have had external beam radiation therapy.My liver enzyme (ALT) levels are within the normal range for my age.I have been diagnosed with myelodysplastic syndrome or a cancer other than neuroblastoma.My child has advanced neuroblastoma with specific genetic features.I am sexually active and not using birth control.I haven't taken strong CYP3A4 drugs in the last week.You have a specific genetic marker called MYCN amplification, or you were diagnosed with cancer at a certain age and with certain tumor characteristics.I have a significant amount of fluid around my heart.I am within 56 to 200 days post my last high-dose chemotherapy and stem cell infusion.I haven't taken any long-acting bone marrow stimulants in the last 14 days.My cancer is advanced but not due to MYCN gene changes.I have completed a specific intense chemotherapy followed by a stem cell transplant.I have not taken seizure medication that affects enzymes in the last week.I've completed 4-6 rounds of intense chemotherapy.I have not worsened on treatments like dinutuximab.I've had 4 or fewer rounds of chemotherapy before my stem cell transplant.My cancer is at a specific stage and has a certain genetic feature.My total bilirubin levels are within normal range for my age.You are currently undergoing other cancer treatments.I am not on any immunosuppressive medications except eculizumab.I have not worsened after treatment with dinutuximab or similar drugs.My kidney function is normal or near normal.My side effects from previous brain treatments are mild.I have moderate to severe diarrhea.I haven't taken high doses of steroids for at least a week.I was initially treated for low-risk neuroblastoma but later found to meet high-risk criteria.I have an infection that isn't responding to treatment.You are pregnant.I do not have trouble breathing when I am resting.My diagnosis is high-risk neuroblastoma or ganglioneuroblastoma.I do not have any active brain or spinal cord diseases.My seizures are well controlled with medication that doesn't speed up drug breakdown.You are a breastfeeding mother who plans to breastfeed during the study.I have received 131I-MIBG therapy before.My neuroblastoma has worsened since my initial diagnosis.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (temozolomide, irinotecan, dinutuximab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap on participant numbers for this research endeavor?
"This clinical trial has since stopped recruiting patients. It was initially published on November 30th 2020 and the last update came out August 17th 2022. If you are seeking alternative studies, there are 161 trials for high risk neuroblastoma that are currently enrolling participants and 496 related to temozolomide looking for patient-subjects."
Answered by AI
For what treatments is temozolomide usually prescribed?
"Temozolomide is primarily prescribed to treat esophageal neoplasms malignant, yet it can also prove useful in cases of refractory acne vulgaris, acute lymphoblastic leukemia (ALL), and melanoma."
Answered by AI
Is this research initiative actively seeking participants?
"This research is no longer accepting new candidates. It was first advertised on the 30th of November, 2020 and most recently updated on August 17th 2022. Other potential studies for high-risk neuroblastoma are plentiful with 161 trials recruiting patients and 496 clinical trials offering Temozolomide interventions available to join."
Answered by AI
What is the regulatory standing of Temozolomide?
"We have assigned Temozolomide a rating of 2, as the data collected so far has shown it to be safe but there is yet no evidence that demonstrates its efficacy."
Answered by AI
What other experimental studies have sought to analyze Temozolomide's effects?
"Presently, 496 clinical trials are being conducted to evaluate the efficacy of Temozolomide. Out of those studies, 84 have entered phase 3 and a total of 14901 medical sites across the world are hosting one or more investigations. The largest concentration is located in Woolloongabba, Queensland."
Answered by AI
How many medical facilities are conducting this research initiative?
"This trial is currently enrolling from Medical City Dallas Hospital, Children's Hospital of Philadelphia, and Riley Hospital for Children. In addition to these 3 sites, there are an additional 70 hospitals participating in the study."
Answered by AI
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