At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of high-risk neuroblastoma (at diagnosis or converted/relapsed to high-risk); patients initially diagnosed as non-high-risk but later converted to high-risk are eligible.
- ✓Must have completed intensive induction chemotherapy, ASCT, and radiotherapy (radiotherapy may be waived for patients with small adrenal masses completely resected upfront or no identifiable primary tumor).
- ✓No more than 12 months from start of first induction chemotherapy to ASCT (for tandem ASCT, from first stem cell infusion); for patients converted to high-risk, 12-month window starts from induction for high-risk disease.
- ✓At pre-ASCT evaluation, must meet International Neuroblastoma Response Criteria (INRC) for CR, VGPR, or PR for primary site, soft tissue metastases, and bone metastases; bone marrow must show ≤10% tumor on bilateral aspirate/biopsy or previously negative marrow with ≤10% tumor at pre-ASCT/pre-enrollment evaluation.
- ✕Progressive disease at time of enrollment, except for protocol-specified bone marrow response and elevations of catecholamines as only sign of disease if baseline catecholamines were normal.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue
In Brief
A Phase 3 clinical trial evaluating Aldesleukin, Dinutuximab, and 5 other interventions for Localized Resectable Neuroblastoma and 5 related conditions. Completed, enrolled 1,449 participants across 197 sites in 5 countries.
Detailed Summary
This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, 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. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.
Study Details
Timeline
Interventions
Given IV
Given IV
Given PO
Correlative studies
Correlative studies
Ancillary studies
Given IV or SC