At a glance
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Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma
In Brief
A Phase 3 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Carboplatin, and 14 other interventions for Localized Resectable Neuroblastoma and 5 related conditions. Completed, enrolled 665 participants across 190 sites in 6 countries.
Detailed Summary
This randomized phase III trial compares two different high-dose chemotherapy regimens followed by a stem cell transplant in treating younger patients with high-risk neuroblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments before a peripheral blood stem cell transplant helps kill any tumor cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. High-dose chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the high- chemotherapy. It is not yet known which regimen of high-dose chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.
Study Details
Timeline
Interventions
Undergo autologous peripheral blood stem cell transplant
Given IV
Given IV
Given IV
Given IV
Given IV
Undergo EBRT
Given IV or SC
Given orally
Correlative studies
Given IV
Undergo autologous peripheral blood stem cell transplant
Correlative studies
Given IV
Given IV
Given IV