153
Participants
Start Date
July 5, 2013
Primary Completion Date
October 21, 2021
Study Completion Date
December 31, 2025
cyclophosphamide
Given intravenously (IV)
topotecan
Given IV
hu14.18K322A
Given IV
peripheral blood stem cell harvest
Following evaluation and approval by a member of the transplant staff and completion of the consent form by the participant, collection of peripheral blood stem cells (PBSC) may take place.
surgical resection
The primary tumor will be resected surgically following two initial courses of chemotherapy, if feasible. Patients who are unable to have their primary tumor resected after the initial two courses of induction chemotherapy will undergo surgery for resection of the primary tumor mass and careful lymph node staging.
cisplatin
Given IV
etoposide
Given IV
doxorubicin
Given IV
vincristine
Given IV
busulfan
Given IV
melphalan
Given IV
peripheral blood stem cell transplantation
Transplantation of previously harvested peripheral blood stem cells.
natural killer cell infusion
Natural killer (NK) cells obtained from a suitable donor will be given together with hu14.18K322A prior to early hematopoietic cell recovery. In the event there is not a suitable parental donor, consenting participants will receive an additional course of hu14.18K322A.
radiation therapy
Radiation therapy to the primary and metastatic disease sites will follow peripheral blood stem cell transplant with the exception of any patient requiring emergent radiotherapy. External beam radiotherapy will be delivered to the primary site and select metastatic and bulky nodal sites.
GM-CSF
Given subcutaneously (SQ)
G-CSF
Given subcutaneously (SQ)
mesna
Given IV
levetiracetam
Given IV
interleukin-2
Given by continuous infusion during MRD maintenance, and SQ during induction.
Isotretinoin
Given orally (PO)
CliniMACS
The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
St. Jude Children's Research Hospital, Memphis
Cookies for Kids' Cancer
OTHER
CURE Childhood Cancer, Inc.
OTHER
St. Jude Children's Research Hospital
OTHER