Treatment of Resistant Langerhans Cell Histiocytosis With ENBREL

January 6, 2020 updated by: Kenneth McClain, Baylor College of Medicine

Treatment of Resistant Langerhans Cell Histiocytosis With Etanercept (ENBREL, IMMUNEX, SEATTLE)

The purpose of this study is to learn about the response of Langerhans cell histiocytosis (LCH) to Enbrel in patients who have failed to respond to standard therapies. We are also looking specifically at what side effects Enbrel has on patients. We expect to enroll 20 patients on this study and anticipate the subjects active participation to last up to one year.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After subjects have completed the pretreatment evaluations, they will receive an injection of Enbrel - the study drug -(given under the skin) twice weekly. If the subjects disease stabilizes or regresses, they may continue to receive treatment for up to 1 year.

Subjects with disease involvement of risk organs (this means patients have disease in their liver, lung, spleen, or bone marrow): will be admitted to the hospital for observation during the first week of administration of Enbrel. If after the first two doses there appears to be no problems, subjects may be followed as an outpatient with twice weekly evaluation visits (similar to those performed before treatment began) until abnormal blood tests have become normal. Then the frequency of clinic visits will decrease and be similar to those described below for subjects without disease involvement of risk organs.

Subjects without disease involvement of risk organs will be treated as an outpatient. While receiving the treatment, subjects may not receive any other chemotherapy agents. Doctors will be monitoring subjects closely for side effects. Most side effects usually disappear after the treatment is stopped. In the meantime, however, the doctor may prescribe medication to keep these side effects under control.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION:

  • Age: Patients of any age greater than 1 year and up to 65 years of age. An internal medicine board-certified physician will also evaluate adult patients.
  • Histologic diagnosis: Patients must have a histologically confirmed LCH that is refractory to standard therapy.
  • Recovery from prior therapy: Patients must have recovered from the toxic effects of all prior therapy but may have abnormal hematologic, hepatic, or other lab values secondary to the disease.
  • Life expectancy: Patients must have a life expectancy of at least 8 weeks.
  • Performance status: Patients must have a Lansky performance status greater than 40 or Karnofsky status greater than 40.
  • Informed consent: All patients or their legal guardians (if the patient is < 18 years of age) must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study. When appropriate the patient will be included in all discussions in order to obtain verbal consent.
  • Hematologic status: Patients of any hematologic status may be enrolled since resistant LCH may require considerable transfusion support.
  • Durable Power of Attorney (DPA): A DPA must be offered to all patients 18 years of age or older.

EXCLUSION:

  • Women of childbearing potential who are pregnant or lactating are excluded.
  • Patients with active infections must be treated prior to entry.
  • Significant other diseases that the investigator feels will complicate review/evaluation of the study data (example: uncontrolled diabetes, multiple sclerosis).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response of Langerhans cell histiocytosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

The Methodist Hospital Research Institute

Investigators

  • Principal Investigator: Kenneth McClain, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion

April 1, 2004

Study Registration Dates

First Submitted

October 30, 2002

First Submitted That Met QC Criteria

October 31, 2002

First Posted (Estimate)

November 1, 2002

Study Record Updates

Last Update Posted (Actual)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10339
  • Etanercept

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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