Protocol

SJGD2: A Phase I Trial of the Humanized Anti-GD2 Antibody (HU14.18K322A) in Children and Adolescents with Neuroblastoma or Melanoma

Diseases

Solid Tumor : Neuroblastoma or melanoma

Description

Hu14.18K322A is a new experimental antibody. Hu14.18K322A are monoclonal antibodies, made in a laboratory, designed to seek out and bind themselves to cancer cells that contain or “express” a certain molecule called a GD2 antigen. Almost all neuroblastoma 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.

Hu14.18K322A will be given (“infused”) into the vein over about 4 hours daily for 4 days every 28 days (4 weeks). One course is 28 days. If patients do not have any serious side effects, and there is no evidence that the disease is getting worse, patients can receive up to 3 additional 4-week courses for a total of 4 courses of treatment (about 4 months).

The main goal of this study is to see how much antibody (the “dose level”) can be given safely. To find the highest safe dose, we will treat research participants with different doses of hu14.18K322A antibody. Once we find a safe dose in one child or one group of participants, the next research participant will receive a higher dose. If serious side effects occur with a certain dose, we will not increase the dose further. The dose of hu14.18K322A antibody patients receive will depend on when they enter the study.

This is the first clinical study with this antibody. Because this antibody has never been tested in humans, all doses of hu14.18K332A antibody will be given in the hospital where doctors and nurses can watch patients closely and treat any side effects as quickly as possible. If a reaction to the drug is seen, the patient will receive additional medications to help lessen these side-effects.


Objectives

  • To learn the highest safe dose of hu14.18K322A antibody that can be given to children and young adults with neuroblastoma 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

  • Patient is ≤ 21 years of age at the time of enrollment
  • Participant has a life expectancy of at least 8 weeks.
  • Must have fully recovered from the acute toxic effects of all prior therapy prior to enrolling on study
  • Has adequate organ function and marrow function as defined by protocol specifications.

 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

Fariba Navid, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

Initial Version dated 8.4.08, IRB approved 8.14.08


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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