Combination Chemotherapy in Treating Young Patients With Langerhans Cell Histiocytosis

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00276757
First received: January 12, 2006
Last updated: January 9, 2014
Last verified: May 2007
  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 sulfate

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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
Study Completion Date: June 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00276757     History of Changes
Other 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: January 9, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Histiocytosis
Histiocytosis, Langerhans-Cell
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Leucovorin
Levoleucovorin
Methylprednisolone
Methylprednisolone Hemisuccinate
Methotrexate
Prednisolone
Vinblastine
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Therapeutic Uses
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on August 26, 2014