A Safety/Feasibility Trial of the Addition of the Humanized Anti-GD2 Antibody (hu14.18K322A) with and without Natural Killer Cells to Chemotherapy in Children and Adolescents with Recurrent/Refractory Neuroblastoma

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Research

Protocol

GD2NK: A Safety/Feasibility Trial of the Addition of the Humanized Anti-GD2 Antibody (hu14.18K322A) with and without Natural Killer Cells to Chemotherapy in Children and Adolescents with Recurrent/Refractory Neuroblastoma

Diseases

Solid Tumor : Recurrent / refractory neuroblastoma

Description

This study is being done to find out if it is safe to give an antibody called hu14.18K322A (anti-GD2 antibody) together with Natural Killer (NK) cell infusions from a donor (usually a parent or other close relative) to children and adolescents with neuroblastoma in combination with chemotherapy.

Relapsed and/or refractory neuroblastoma is difficult to treat and cure. For this study we are adding two investigational treatments to standard chemotherapy to see if it is feasible (safe and possible) to give to patients with neuroblastoma. The first experimental treatment involves the use of a new experimental (investigational) antibody called hu14.18K322A. This antibody is manufactured at the Children’s GMP, LLC, which is here at St. Jude. The second experimental treatment uses donor natural killer (NK) cells together with chemotherapy. NK cells are special cells in our immune system that specifically target cancer cells and cells that are infected by viruses.

Objectives

To learn what kind of side effects (good or bad) the hu14.18K322A antibody and NK cells can cause when given with chemotherapy to children and young adults with neuroblastoma.
To find out if it is feasible (safe and possible) to give this treatment.
To study how the body uses hu14.18K322A antibody (pharmacokinetic studies).
To determine if the body makes antibodies to hu14.18K322A antibody.
To determine whether this treatment will make the tumor smaller.
To study the blood and tumor tissue of research participants who have received this treatment to find out more about this treatment.

Eligibility

A patient will be eligible for the study if they have recurrent or refractory neuroblastoma.
A patient will be eligible for the study if they are < 22 years at time of enrollment (e.g. participant is eligible until 22^nd birthday).

A patient will not be eligible to participate in the study if they are pregnant or breast-feeding or the research participant or legal guardian/representative are unable or unwilling to give written informed consent.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Wayne Furman, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
FAX: 901-595-4011

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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