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

> **NCT04385277** · PHASE2 · ACTIVE_NOT_RECRUITING · sponsor: **Children's Oncology Group** · enrollment: 41 (actual)

## Conditions studied

- Ganglioneuroblastoma, Nodular
- Neuroblastoma

## Interventions

- **PROCEDURE:** Biospecimen Collection
- **PROCEDURE:** Bone Marrow Aspiration
- **PROCEDURE:** Bone Marrow Biopsy
- **PROCEDURE:** Computed Tomography
- **BIOLOGICAL:** Dinutuximab
- **PROCEDURE:** FDG-Positron Emission Tomography
- **RADIATION:** Iobenguane I-123
- **DRUG:** Irinotecan
- **DRUG:** Isotretinoin
- **PROCEDURE:** Magnetic Resonance Imaging
- **PROCEDURE:** Multigated Acquisition Scan
- **BIOLOGICAL:** Sargramostim
- **DRUG:** Temozolomide

## Key facts

- **NCT ID:** NCT04385277
- **Lead sponsor:** Children's Oncology Group
- **Sponsor class:** NETWORK
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2020-12-31
- **Primary completion:** 2023-06-30
- **Final completion:** 2027-09-30
- **Target enrollment:** 41 (ACTUAL)
- **Last updated:** 2025-10-27

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04385277

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04385277, "Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT04385277. Licensed CC0.

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