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Treatment of Resistant Langerhans Cell Histiocytosis With ENBREL

Primary Purpose

Histiocytosis, Langerhans-Cell

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Etanercept
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Histiocytosis, Langerhans-Cell focused on measuring LANGERHANS, HISTIOCYTOSIS

Eligibility Criteria

1 Day - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Texas Children's Hospital

Outcomes

Primary Outcome Measures

Response of Langerhans cell histiocytosis

Secondary Outcome Measures

Full Information

First Posted
October 30, 2002
Last Updated
January 6, 2020
Sponsor
Baylor College of Medicine
Collaborators
The Methodist Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00048373
Brief Title
Treatment of Resistant Langerhans Cell Histiocytosis With ENBREL
Official Title
Treatment of Resistant Langerhans Cell Histiocytosis With Etanercept (ENBREL, IMMUNEX, SEATTLE)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
The Methodist Hospital Research Institute

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Histiocytosis, Langerhans-Cell
Keywords
LANGERHANS, HISTIOCYTOSIS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Etanercept
Primary Outcome Measure Information:
Title
Response of Langerhans cell histiocytosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth McClain, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Treatment of Resistant Langerhans Cell Histiocytosis With ENBREL

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