At a glance
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A Pilot Induction Regimen Incorporating Chimeric 14.18 Antibody (ch14.18, Dinutuximab) (NSC# 764038) and Sargramostim (GM-CSF) for the Treatment of Newly Diagnosed High-Risk Neuroblastoma
In Brief
A Phase 2 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Carboplatin, and 13 other interventions for Ganglioneuroblastoma and High Risk Neuroblastoma. Completed, enrolled 42 participants across 10 sites in 3 countries.
Signals
Detailed Summary
This phase II pilot trial studies the side effects and how well dinutuximab and sargramostim work when combined with chemotherapy in patients with high-risk neuroblastoma. 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. Sargramostim helps the body produce normal infection-fighting white blood cells. These cells also help the dinutuximab work better. Giving chemotherapy before a stem cell transplant, with drugs such as cisplatin, etoposide, vincristine, doxorubicin, cyclophosphamide, thiotepa, melphalan, etoposide, carboplatin, topotecan, and isotretinoin, helps kill cancer cells that are in the body and helps make room in a patient's bone marrow for new blood-forming cells (stem cells). Giving dinutuximab and sargramostim with combination chemotherapy may work better than combination chemotherapy alone in treating patients with high-risk neuroblastoma.
Study Details
Timeline
Arms & Interventions
See Detailed Description
Interventions
Undergo ASCT
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Undergo EBRT
Given PO
Given IV
Given SC
Given IV
Given IV
Given IV