HGS-ETR2 to Treat Children With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00428272|
Recruitment Status : Terminated
First Posted : January 29, 2007
Last Update Posted : May 18, 2018
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Ewing's Sarcoma Osteosarcoma Neuroblastoma Rhabdomyosarcoma||Drug: Lexatumumab alone Drug: Lexatumumab in combination Drug: Interferon gamma 1b in combination Drug: Gamma 1b potential expansion||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Monoclonal Antibody HGS-ETR2 (Lexatumumab) With or Without Interferon Gamma in Patients With Refractory Pediatric Solid Tumors|
|Study Start Date :||December 4, 2006|
|Actual Primary Completion Date :||April 28, 2011|
|Actual Study Completion Date :||October 9, 2015|
Lexatumumab alone dose escalation
Drug: Lexatumumab alone
Dose escalation : 3mg/kg, 5mg/kg, 8mg/kg, 10mg/kg
Lexatumumab with interferon - dose escalation
Drug: Lexatumumab in combination
Dose escalation : 1mg/kg, 3mg/kg, 5mg/kg, 8mg/kg, 10mg/kgDrug: Interferon gamma 1b in combination
Dosing at the following for each lexatumumab dose level: .75mcg/m2/dose and 25mcg/m2/dose
Lexatumumab 10mg/kg with interferon expansion at
Drug: Lexatumumab in combination
Dose escalation : 1mg/kg, 3mg/kg, 5mg/kg, 8mg/kg, 10mg/kgDrug: Gamma 1b potential expansion
Potential expansion (at 10mg/kg lexatumumab): 1.5mcg/m2/dose and 50mcg/m2/dose
- Asult MTD and DLTs of lexatumumab [ Time Frame: 6 months ]
- MTD of lexatumumab w/interferon gamma 1b [ Time Frame: 6 months ]
- Pharmacokinetics [ Time Frame: 2 years ]
- Tumor response rate [ Time Frame: 2 years ]
- Correlation of immunohistochemical expression of pro-apoptotic proteins with response to therapy [ Time Frame: 2 years ]
- Determine if anti-HGS-ETR2 antibodies are produced [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428272
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Crystal L Mackall, M.D.||National Cancer Institute (NCI)|