Combination Chemotherapy in Treating Young Patients With Langerhans Cell Histiocytosis - Full Text View

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:

Genetics Home Reference related topics: Langerhans cell histiocytosis pulmonary alveolar microlithiasis

Drug Information available for: Prednisolone Methotrexate Vinblastine sulfate Vinblastine Leucovorin calcium

Genetic and Rare Diseases Information Center resources: Langerhans Cell Histiocytosis Hand-Schuller-Christian Disease

U.S. FDA Resources

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


Estimated Enrollment:	376
Study Start Date:	April 2001
Study Completion Date:	June 2013

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Eligibility


Ages Eligible for Study:	up to 17 Years (Child)
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gadner H, Minkov M, Grois N, Pötschger U, Thiem E, Aricò M, Astigarraga I, Braier J, Donadieu J, Henter JI, Janka-Schaub G, McClain KL, Weitzman S, Windebank K, Ladisch S; Histiocyte Society. Therapy prolongation improves outcome in multisystem Langerhans cell histiocytosis. Blood. 2013 Jun 20;121(25):5006-14. doi: 10.1182/blood-2012-09-455774. Epub 2013 Apr 15.


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 Methotrexate Prednisolone Vinblastine Levoleucovorin Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs 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 Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on September 23, 2016