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~8 spots leftby Mar 2026

Chemo-Immunotherapy for High-Risk Neuroblastoma

Recruiting in Palo Alto (17 mi)

+77 other locations

Overseen ByAmi V Desai

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies if dinutuximab, GM-CSF, isotretinoin in combination with irinotecan, and temozolomide (chemo-immunotherapy) can be given safely to patients with high-risk neuroblastoma after Consolidation therapy (which usually consists of two autologous stem cell transplants and radiation) who have not experienced worsening or recurrence of their disease. Dinutuximab represents a kind of cancer therapy called immunotherapy. Unlike chemotherapy and radiation, dinutuximab targets the cancer cells without destroying nearby healthy cells. Sargramostim helps the body produce normal infection-fighting white blood cells. Isotretinoin helps the neuroblastoma cells become more mature. These 3 drugs (standard immunotherapy) are already given to patients with high-risk neuroblastoma after Consolidation because they have been proven to be beneficial in this setting. Chemotherapy drugs, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. They may also affect how well immunotherapy works on neuroblastoma cells. Giving chemo-immunotherapy after intensive therapy may work better in treating patients with high-risk neuroblastoma compared to standard immunotherapy.

Eligibility Criteria

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.

Inclusion Criteria

My cancer is advanced with specific genetic changes.

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 have completed 4-6 cycles of high-risk chemotherapy.

I can take care of myself but may not be able to do heavy physical work.

My liver enzyme (ALT) levels are within the normal range for my age.

My child has advanced neuroblastoma with specific genetic features.

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'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.

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 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.

Exclusion Criteria

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

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

I experience symptoms of heart failure.

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

I am sexually active and not using birth control.

I have a significant amount of fluid around my heart.

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

I am not on any immunosuppressive medications except eculizumab.

I have moderate to severe diarrhea.

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

I have received 131I-MIBG therapy before.

Participant Groups

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.

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.

Dinutuximab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Unituxin for: