HGS-ETR2 to Treat Children With Solid Tumors

Stopped early · Phase 1

Conditions studied: Ewing's Sarcoma, Osteosarcoma, Neuroblastoma, Rhabdomyosarcoma

In brief

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.

Key facts

Study ID

NCT00428272

Run by

National Cancer Institute (NCI)

People needed

30

Starts

2006-12-04

Expected to finish

2015-10-09

Last updated by the study team

2019-12-17

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Clinically significant unrelated systemic illness, such as serious infections or organ dysfunction, which in the judgment of the Principal or Associate Investigators would compromise the patient s ability to tolerate the agents in this trial or are likely to interfere with the study procedures or results.
• Patients with a history of allogeneic bone marrow transplantation. Patients who have received autologous stem cell transplantation are eligible greater than 3 months after completion of therapy if they meet other eligibility requirements.
• Patients with hepatic tumors or metastases are excluded due to the potential for hepatotoxicity with agents that target the TRAIL-R pathway. Patients with primary CNS tumors will be excluded due to unknown penetration into the CNS.
• Untreated CNS metastases will render the patient ineligible however patients with a previous history of CNS metastases are eligible if: the metastases have been treated with surgery and/or radiotherapy, are clinically stable as evidenced by no requirements for corticosteroids, the patient has no evolving neurologic deficits and no change in residual brain abnormalities without specific therapy over 6 weeks.
• Pregnant or breastfeeding females are excluded because the risks of lexatumumab to the developing fetus or nursing child are unknown.
• Patients currently receiving other investigational agents.
• History of any infection requiring hospitalization or parenteral antibiotics within 2 weeks of study entry.
• Co-existing medical illness that would place the subject at undue risk.
• On immunosupressant therapy (with the exception of prednisone up to 10 mg/day, or dexamethasone up to 4 mg/day), or with known human immunodeficiency virus (HIV) infection or hepatitis B or C. Subjects with immune deficiency are excluded due to their increased risk of life threatening toxicity when treated with anticancer agents.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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