Background
- 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.
Objectives:
- 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.
Eligibility:
-Patients 1 to 21 years of age with solid cancers that do not respond to standard therapy.
Design:
- 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.