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HGS-ETR2 to Treat Children With Solid Tumors

NCT00428272 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-12-17

No results posted yet for this 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.

Conditions

Interventions

DRUG

Lexatumumab alone

Dose escalation : 3mg/kg, 5mg/kg, 8mg/kg, 10mg/kg

DRUG

Lexatumumab in combination

Dose escalation : 1mg/kg, 3mg/kg, 5mg/kg, 8mg/kg, 10mg/kg

DRUG

Interferon gamma 1b in combination

Dosing at the following for each lexatumumab dose level: .75mcg/m2/dose and 25mcg/m2/dose

DRUG

Gamma 1b potential expansion

Potential expansion (at 10mg/kg lexatumumab): 1.5mcg/m2/dose and 50mcg/m2/dose

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Crystal L Mackall, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-04
Primary Completion
2011-04-28
Completion
2015-10-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00428272 on ClinicalTrials.gov