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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

Must not have

Received additional systemic cancer-directed therapy following completion of the last planned high-dose chemotherapy with ASCT

Received single (rather than tandem) high-dose chemotherapy with ASCT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of start of protocol therapy to death, assessed at 1 year.

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had more cancer treatment after my high-dose chemo and stem cell transplant.

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I had one high-dose chemotherapy session with stem cell transplant.

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I experience symptoms of heart failure.

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I have been diagnosed with myelodysplastic syndrome or a cancer other than neuroblastoma.

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I am sexually active and not using birth control.

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I have a significant amount of fluid around my heart.

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I have not taken seizure medication that affects enzymes in the last week.

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I am not on any immunosuppressive medications except eculizumab.

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I have moderate to severe diarrhea.

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I have an infection that isn't responding to treatment.

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I have received 131I-MIBG therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of start of protocol therapy to the occurrence of disease relapse or progression, secondary malignancy, or death, assessed at 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of start of protocol therapy to the occurrence of disease relapse or progression, secondary malignancy, or death, assessed at 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of start of protocol therapy to the occurrence of disease relapse or progression, secondary malignancy, or death, assessed at 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Patients Who Complete 5 Cycles of Dinutuximab + Chemotherapy Without Progressive Disease (PD)

Secondary study objectives

Event-free Survival (EFS)

Overall Survival (OS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2790

Multigated Acquisition Scan

2015

Completed Phase 3

~270