Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma

Conditions

• High Risk Neuroblastoma
• Recurrent Neuroblastoma
• Refractory Neuroblastoma

Eligibility Criteria

Sex

ALL

Age

1 Year - N/A

Healthy Volunteers

Not accepted

Interventions

• Dinutuximab — BIOLOGICAL
  Given IV
• Eflornithine Hydrochloride — DRUG
  Given PO or via NG or G tube
• Irinotecan Hydrochloride — DRUG
  Given IV
• Sargramostim — BIOLOGICAL
  Given SC or IV
• Temozolomide — DRUG
  Given PO or via NG or G tube

Study Details

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.

Key Dates

First listed

Jan 7, 2019

Start date

Jul 8, 2019

Status verified

Feb 2026

Primary completion

Mar 31, 2025

Completion

Mar 31, 2029

Study Design

Enrollment

94 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Regimen A (chemotherapy, dinutuximab, sargramostim)
  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.
• Experimental: Regimen B (eflornithine, chemotherapy, dinutuximab)
  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.

Primary Outcome Measure

Response Rate [ Time Frame: After every 2 cycles, for a maximum of 6 cycles of treatment (each cycle is 21 days) ]

Locations (124)

Find similar trials in Birmingham, AL

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