HGS-ETR2 to Treat Children With Solid Tumors
This study has been completed.
Information provided by:
National Institutes of Health Clinical Center (CC)
First received: January 25, 2007
Last updated: November 27, 2013
Last verified: January 2013
- HGS-ETR2 is a monoclonal antibody, produced in the laboratory from human genes.
- HGS-ETR2 targets a protein called the TRAIL receptor that is located on the surface of some tumor cells. When the TRAIL receptor is activated, it can cause the tumor cell to self-destruct.
- To determine the highest dose of HGS-ETR2 that can be given safely in children and young adults with cancer.
- To study the pharmacology (how the body handles the drug) of HGS-ETR2 by measuring the amount of drug in the bloodstream over time before and after a dose is given to the patient.
- To determine if HGS-ETR2 can stop or slow tumor growth.
- To determine whether proteins in tumor tissue before treatment can predict whether the tumor will respond to HGS-ETR2 therapy.
-Patients 1 to 21 years of age with solid cancers that do not respond to standard therapy.
- HGS-ETR2 is given through a vein (intravenously, IV) once every 14 days. Each treatment cycle is 28 days long and consists of two doses of HGS-ETR2.
- The dose of HGS-ETR2 is increased in successive small groups of patients until the maximum tolerated dose (highest dose with acceptable side effects) is determined.
- During the treatment period, patients have a physical examination at least once a week, and routine blood tests at least twice a week. These tests are done less frequently in later treatment cycles.
- Additional blood samples are drawn for immunology and pharmacology studies.
- Tests to monitor the size of the tumor (X-rays, CT scans, MRI, PET scans) are done periodically throughout the treatment period.
- Patients may continue to receive HGS-ETR2 until unacceptable side effects develop or the tumor grows.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Trial of Monoclonal Antibody HGS-ETR2 (Lexatumumab) With or Without Interferon Gamma in Patients With Refractory Pediatric Solid Tumors|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcome Measures:
- To determine the tolerance of the adult maximum tolerated dose and dose limiting toxicities of lexatumumab in patients with refractory pediatric solid tumors.
Secondary Outcome Measures:
- To quantify tumor response to HGS-ETR2.
|Study Start Date:||December 2006|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Intervention Details:Show Detailed Description
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428272
|United States, Maryland|
|National Cancer Institute (NCI), 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229-3039|
Sponsors and Collaborators
|Principal Investigator:||Crystal L Mackall, M.D.||National Cancer Institute (NCI)|