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Combination Chemotherapy in Treating Young Patients With Langerhans Cell Histiocytosis
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2007
First Received: January 12, 2006   Last Updated: June 9, 2009   History of Changes
Sponsored by: Histiocyte Society
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00276757
  Purpose

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 Intervention
Childhood Langerhans Cell Histiocytosis
Drug: leucovorin calcium
Drug: methotrexate
Drug: prednisolone
Drug: vinblastine

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Treatment Protocol of the Third International Study For Langerhans Cell Histiocytosis

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 376
Study Start Date: April 2001
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276757

  Show 33 Study Locations
Sponsors and Collaborators
Histiocyte Society
Investigators
Study Chair: Kenneth L. McClain, MD, PhD Texas Children's Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000454768, HISTSOC-LCH-III, CCLG-LCH-III, EU-20587, CCLG-LCH-2002-07, UMN-2006NT004
Study First Received: January 12, 2006
Last Updated: June 9, 2009
ClinicalTrials.gov Identifier: NCT00276757     History of Changes
Health Authority: Unspecified

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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Antimetabolites
Immunologic Factors
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Folate
Leucovorin
Vinblastine
Prednisolone acetate
Hormones
Vitamin B9
Histiocytosis X
Respiratory Tract Diseases
Histiocytosis
Vitamins
Methotrexate
Micronutrients
Methylprednisolone Hemisuccinate
Langerhans Cell Histiocytosis
Letterer-Siwe Disease
Lung Diseases, Interstitial
Vitamin B Complex
Antineoplastic Agents, Hormonal
Methylprednisolone acetate
Trace Elements
Antimitotic Agents
Folinic Acid
Histiocytosis, Langerhans-Cell
Folic Acid Antagonists

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Leucovorin
Vinblastine
Reproductive Control Agents
Hormones
Respiratory Tract Diseases
Histiocytosis
Vitamins
Therapeutic Uses
Abortifacient Agents
Methotrexate
Micronutrients
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Lung Diseases, Interstitial
Vitamin B Complex
Reticuloendotheliosis
Antineoplastic Agents, Hormonal
Growth Substances
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on July 02, 2009