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: March 14, 2014
Last verified: December 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:
Genetic and Rare Diseases Information Center resources: Malignant Mesenchymal Tumor Soft Tissue Sarcoma Neuroblastoma Osteosarcoma Bone Cancer Ewing's Sarcoma Ewing's Family of TumorsU.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)|