Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma
NCT03786783 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2026-04-13
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.
Conditions
- Ganglioneuroblastoma
- High Risk Neuroblastoma
Interventions
- PROCEDURE
-
Autologous Hematopoietic Stem Cell Transplantation
Undergo ASCT
- DRUG
-
Given IV
- DRUG
-
Given IV
- DRUG
-
Given IV
- DRUG
-
Dexrazoxane
Given IV
- BIOLOGICAL
-
Dinutuximab
Given IV
- DRUG
-
Doxorubicin
Given IV
- DRUG
-
Etoposide
Given IV
- RADIATION
-
External Beam Radiation Therapy
Undergo EBRT
- DRUG
-
Isotretinoin
Given PO
- DRUG
-
Melphalan
Given IV
- BIOLOGICAL
-
Sargramostim
Given SC
- DRUG
-
Thiotepa
Given IV
- DRUG
-
Topotecan
Given IV
- DRUG
-
Vincristine
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Sara M Federico · Children's Oncology Group
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-04
- Primary Completion
- 2021-12-31
- Completion
- 2026-09-19
- FDA Drug
- Yes
Countries
- United States
- Australia
- New Zealand
Study Locations
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