Protocol

SJGD2: A Phase I trial of the humanized anti-GD2 antibody (hu12.18K322A) in children and adolescents with neuroblastoma, osteosarcoma and melanoma

Diseases

Solid Tumor : Neuroblastoma, osteosarcoma and melanoma

Description

This study is for participants who have neuroblastoma, osteosarcoma or melanoma that has either come back (relapsed) or did not respond to treatment (refractory). Treatment in these cases can be difficult and it is likely that any treatment we can offer now will not result in a cure. This study is being done to find out if it is safe to give an antibody called hu14.18K322A to children and adolescents with neuroblastoma, osteosarcoma or melanoma.

Antibodies are part of the body’s normal immune (defense) system that help to look for and attack certain cells that it sees as “different” and harmful such as bacteria, viruses, and cancer cells. Hu14.18K322A is called a “monoclonal antibody.” Monoclonal antibodies are proteins made in laboratories, and are designed to seek out and attach (bind) themselves to specific cancer cells. Hu14.18K322A was designed to bind to cancer cells that contain or “express” a certain molecule called a GD2 antigen. Almost all neuroblastoma and most osteosarcoma and melanoma cells express GD2 antigen. When hu14.18K322A antibody binds to these types of cancer cells, it is hoped that the body’s immune system will be stimulated (pushed) to attack and kill the cancer cells without destroying nearby healthy cells.

Objectives

• To learn the highest safe dose of hu14.18K322A antibody that can be given to children and young adults with neuroblastoma,osteosarcoma or melanoma.
• To learn what kind of side effects (good or bad) hu14.18K322A antibody can cause in children and young adults with neuroblastoma and melanoma.
• To study how the body uses hu14.18K322A antibody (pharmacokinetic studies).
• To determine whether this treatment is beneficial for your tumor
• To determine if the body makes antibodies to hu14.18K322A antibody

Eligibility Criteria, among others include:

• Participant with neuroblastoma or melanoma is ≤ 21 years of age at the time of enrollment or
• Participant with osteosarcoma is > 12 years of age and < 21 years of age at the time of enrollment
• Participant has recurrent or refractory:
  • Neuroblastoma
  • Melanoma
  • Osteosarcoma

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital.

Contact

Fariba Navid, 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.