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NCT00428272 · ClinicalTrials.gov registry record · Phase 1
HGS-ETR2 to Treat Children With Solid Tumors
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00428272: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00428272 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00428272, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Lexatumumab alone
- DRUG Lexatumumab in combination
- DRUG Interferon gamma 1b in combination
- DRUG Gamma 1b potential expansion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-12-04 |
| Est. Completion | 2015-10-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00428272
The ClinicalTrials.gov registry entry for NCT00428272 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Lexatumumab alone is the first listed.
NCT00428272 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00428272 about?
NCT00428272 is a clinical study titled "HGS-ETR2 to Treat Children With Solid Tumors". 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: *...
What is the current status of trial NCT00428272?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2006-12-04. Estimated completion is 2015-10-09.
What interventions are being tested in trial NCT00428272?
The interventions under investigation include: Lexatumumab alone (DRUG), Lexatumumab in combination (DRUG), Interferon gamma 1b in combination (DRUG), Gamma 1b potential expansion (DRUG).
Who is sponsoring clinical trial NCT00428272?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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