Therapy for Children With Advanced Stage Neuroblastoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

July 5, 2013

Primary Completion Date

October 21, 2021

Study Completion Date

December 31, 2025

Conditions
Neuroblastoma
Interventions
DRUG

cyclophosphamide

Given intravenously (IV)

DRUG

topotecan

Given IV

BIOLOGICAL

hu14.18K322A

Given IV

PROCEDURE

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.

PROCEDURE

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.

DRUG

cisplatin

Given IV

DRUG

etoposide

Given IV

DRUG

doxorubicin

Given IV

DRUG

vincristine

Given IV

DRUG

busulfan

Given IV

DRUG

melphalan

Given IV

BIOLOGICAL

peripheral blood stem cell transplantation

Transplantation of previously harvested peripheral blood stem cells.

BIOLOGICAL

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

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.

BIOLOGICAL

GM-CSF

Given subcutaneously (SQ)

BIOLOGICAL

G-CSF

Given subcutaneously (SQ)

DRUG

mesna

Given IV

DRUG

levetiracetam

Given IV

BIOLOGICAL

interleukin-2

Given by continuous infusion during MRD maintenance, and SQ during induction.

DRUG

Isotretinoin

Given orally (PO)

DEVICE

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.

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
collaborator

Cookies for Kids' Cancer

OTHER

collaborator

CURE Childhood Cancer, Inc.

OTHER

lead

St. Jude Children's Research Hospital

OTHER