Treatment of Resistant Langerhans Cell Histiocytosis With ENBREL

NCT00048373 | Completed Phase 2

• 2 other identifiers: H10339Etanercept
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Histiocytosis, Langerhans-Cell

Keywords

LANGERHANS; HISTIOCYTOSIS

Outcome Measures

Primary Outcomes (1)

• Response of Langerhans cell histiocytosis

Interventions

Etanercept DRUG

Eligibility Criteria

• Age: 1 Day - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Histiocytosis, Langerhans-Cell; Histiocytosis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Kenneth McClain, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatrics-Oncology

Study Record Dates

• First Submitted: October 30, 2002
• First Posted: November 1, 2002
• Study Start: October 1, 2001
• Study Completion: April 1, 2004
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

US (1)