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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.
 
ClinicalTrials.gov Identifier: NCT00276757
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : January 10, 2014
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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 Phase
Childhood Langerhans Cell Histiocytosis Drug: leucovorin calcium Drug: methotrexate Drug: prednisolone Drug: vinblastine sulfate Not Applicable

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Study Design
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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
Actual Study Completion Date : June 2013

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

  • No prior treatment for Langerhans cell histiocytosis
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00276757


Locations
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Sponsors and Collaborators
Histiocyte Society
Investigators
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Study Chair: Kenneth L. McClain, MD, PhD Texas Children's Cancer Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00276757    
Other Study ID Numbers: CDR0000454768
HISTSOC-LCH-III
CCLG-LCH-III
EU-20587
CCLG-LCH-2002-07
UMN-2006NT004
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:
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Histiocytosis, Langerhans-Cell
Histiocytosis
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Leucovorin
Prednisolone
Methotrexate
Vinblastine
Calcium
Levoleucovorin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
 Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antidotes
Protective Agents