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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

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

ChemIDplus related topics:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Methotrexate    Prednisolone    6-Methylprednisolone    Depo-medrol    Medrol veriderm    Methylprednisolone    Methylprednisolone hemisuccinate    Methylprednisolone Sodium Succinate    Prednisolone acetate    Prednisolone sodium phosphate    Prednisolone Sodium Succinate    Calcium gluconate    Vinblastine    Vinblastine sulfate   

U.S. FDA Resources

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

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

Estimated Enrollment:   376
Study Start Date:   April 2001

Show detailed description  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  Show 33 Study Locations

Sponsors and Collaborators
Histiocyte Society

Investigators
Study Chair:     Kenneth L. McClain, MD, PhD     Texas Children's Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000454768, HISTSOC-LCH-III, CCLG-LCH-III, EU-20587, CCLG-LCH-2002-07, UMN-2006NT004
First Received:   January 12, 2006
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00276757
Health Authority:   Unspecified

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

Study placed in the following topic categories:
Lung Diseases, Interstitial
Methylprednisolone
Leucovorin
Methylprednisolone acetate
Prednisolone acetate
Vinblastine
Langerhans cell histiocytosis
Histiocytosis, Langerhans-Cell
Histiocytosis X
Folic Acid
Lymphatic Diseases
Letterer-Siwe disease
Histiocytosis
Respiratory Tract Diseases
Lung Diseases
Prednisolone
Methotrexate
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Therapeutic Uses
Vitamins
Abortifacient Agents
Micronutrients
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Vitamin B Complex
Reticuloendotheliosis
Antineoplastic Agents, Hormonal
Growth Substances
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Glucocorticoids
Pharmacologic Actions
Tubulin Modulators
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 05, 2008




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