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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.

Must not have

Patients on any other immunosuppressive medications (e.g. cyclosporine, tacrolimus)

Patients with symptoms of congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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

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I have symptoms of heart failure.

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I have not been treated with irinotecan and temozolomide.

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

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

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I do not have moderate to severe diarrhea.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

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

Primary study objectives

Response rate

Secondary study objectives

Incidence of adverse events >= Grade 3 (Regimen B)

Overall survival (OS)

Progression-free survival (PFS)

Other study objectives

GD2 levels in tumor cells from bone marrow samples

Immune and cytokine profiles

Patient reported pain and opiate usage

Awards & Highlights

No Placebo-Only Group

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

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

Sargramostim

2006

Completed Phase 4

~850

Temozolomide

2010

Completed Phase 3

~1880