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~0 spots leftby Mar 2025

Combination Chemotherapy for Neuroblastoma

Recruiting in Palo Alto (17 mi)

+153 other locations

Overseen ByMargaret E Macy

Age: Any Age

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

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back (relapsed) or that isn't responding to treatment (refractory). Drugs used in chemotherapy, such as irinotecan hydrochloride 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. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.

Eligibility Criteria

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.

Inclusion Criteria

My cancer is confirmed as neuroblastoma or ganglioneuroblastoma with high urinary catecholamines.

My condition worsened for the first time despite strong initial treatment.

My scan shows active cancer that has returned or is not responding to treatment.

I have no active brain or spinal cord disease.

I can care for myself but may not be able to do active work.

I've had 4+ cycles of initial chemo for high-risk cancer but no second-line treatment for relapse.

My neuroblastoma did not respond well to initial intense chemotherapy.

I have a tumor visible on scans or confirmed neuroblastoma in my bone marrow.

My tumor is visible and measurable on a scan.

It's been over 21 days since my last antibody treatment and any side effects are mild.

I don't have trouble breathing at rest, can exercise, don't need oxygen, and my oxygen levels are good.

I haven't taken any cancer medication that lowers blood counts in the last 7 days.

My cancer was confirmed through tests and I have high levels of certain chemicals in my urine.

My bone marrow disease involves more than 5% neuroblastoma cells.

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

My high-risk disease has returned after I completed an intense treatment.

It has been over 2 weeks since my last treatment that lowers my blood cell counts.

My kidney function is within the required range for my age and gender.

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

I am receiving a strong chemotherapy that includes drugs from two specific classes.

I have had a stem cell infusion treated with a special process.

My brain-related side effects are mild.

Exclusion Criteria

I am not taking any immunosuppressive medications like cyclosporine or tacrolimus.

I have symptoms of heart failure.

I have not been treated with irinotecan and temozolomide.

I have not been diagnosed with myelodysplastic syndrome or any cancer other than neuroblastoma.

I had a severe allergic reaction to anti-GD2 cancer therapy.

I do not have moderate to severe diarrhea.

I do not have any infections that aren't responding to treatment.

Participant Groups

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.

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.

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

🇺🇸 Approved in United States as Unituxin for: