Combination Chemotherapy in Treating Young Patients With Langerhans Cell Histiocytosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00276757
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : January 10, 2014
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of Langerhans cell histiocytosis, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may be an effective treatment for Langerhans cell histiocytosis.

PURPOSE: This randomized clinical trial is studying combination chemotherapy to see how well it works in treating young patients with Langerhans cell histiocytosis.

Condition or disease Intervention/treatment
Childhood Langerhans Cell Histiocytosis Drug: leucovorin calcium Drug: methotrexate Drug: prednisolone Drug: vinblastine sulfate

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 376 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Treatment Protocol of the Third International Study For Langerhans Cell Histiocytosis
Study Start Date : April 2001
Study Completion Date : June 2013

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histopathologically confirmed diagnosis of Langerhans cell histiocytosis according to the criteria defined by the Histiocyte Society

    • Demonstration of CD1a antigenic determinants on the surface of lesional cells (by immunocytology or immunohistology) or Birbeck granules in lesional cells by electron microscopy
  • Considered at risk or low risk according to the following criteria:

    • Multi-system at risk disease, defined as involvement of one or more risk organs (i.e., hematopoietic system, liver, spleen, or lungs)

      • No single-system lung involvement
    • Multi-system low-risk disease

      • Multiple organs involved but without involvement of risk organs
    • Single-system disease

      • Multifocal bone disease (i.e., lesions in 2 or more different bones)
      • Localized special site involvement, such as CNS-risk lesions with intracranial soft tissue extension or vertebral lesions with intraspinal soft tissue extension

        • Vault lesions are not regarded as CNS-risk lesions


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


  • No prior treatment for Langerhans cell histiocytosis

Information from the National Library of Medicine

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 identifier (NCT number): NCT00276757

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Sponsors and Collaborators
Histiocyte Society
Study Chair: Kenneth L. McClain, MD, PhD Texas Children's Cancer Center

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00276757     History of Changes
Other Study ID Numbers: CDR0000454768
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: May 2007

Keywords provided by National Cancer Institute (NCI):
childhood Langerhans cell histiocytosis

Additional relevant MeSH terms:
Histiocytosis, Langerhans-Cell
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal