Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)

Conditions

• Ganglioneuroblastoma, Nodular
• Neuroblastoma

Eligibility Criteria

Sex

ALL

Age

N/A - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Correlative studies
• Bone Marrow Aspiration — PROCEDURE
  Undergo BM aspiration
• Bone Marrow Biopsy — PROCEDURE
  Undergo BM biopsy
• Computed Tomography — PROCEDURE
  Undergo CT
• Dinutuximab — BIOLOGICAL
  Given IV
• FDG-Positron Emission Tomography — PROCEDURE
  Undergo FDG-PET
• Iobenguane I-123 — RADIATION
  Undergo 123I-MIBG
• Irinotecan — DRUG
  Given IV
• Isotretinoin — DRUG
  Given PO
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA
• Sargramostim — BIOLOGICAL
  Given SC or IV
• Temozolomide — DRUG
  Given PO or via enteral tube

Study Details

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.

Key Dates

Start date

Dec 31, 2020

Status verified

Oct 2025

Primary completion

Jun 30, 2023

Completion

Sep 30, 2027

Study Design

Enrollment

41 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (temozolomide, irinotecan, dinutuximab)
  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.

Primary Outcome Measure

Percentage of Patients Who Complete 5 Cycles of Dinutuximab + Chemotherapy Without Progressive Disease (PD) [ Time Frame: Within 30 weeks from the date of first treatment ]

Locations (70)

Find similar trials in Mesa, AZ

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