Combination Chemotherapy in Treating Young Patients With Langerhans Cell Histiocytosis
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ClinicalTrials.gov Identifier: NCT00276757 |
Recruitment Status :
Completed
First Posted : January 13, 2006
Last Update Posted : January 10, 2014
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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 |
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Childhood Langerhans Cell Histiocytosis | Drug: leucovorin calcium Drug: methotrexate Drug: prednisolone Drug: vinblastine sulfate | Not Applicable |

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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Ages Eligible for Study: | up to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
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Considered at risk or low risk according to the following criteria:
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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
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Multi-system low-risk disease
- Multiple organs involved but without involvement of risk organs
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Single-system disease
- Multifocal bone disease (i.e., lesions in 2 or more different bones)
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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
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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

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

Study Chair: | Kenneth L. McClain, MD, PhD | Texas Children's Cancer Center |
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 |
childhood Langerhans cell histiocytosis |
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 |