Methotrexate and Cytosine in Adult Langerhans Cell Histiocytosis

Study Overview
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Brief Summary
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Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment purpose: This single arm clinical trial is studying efficacy and tolerance of combination chemotherapy with methotrexate and cytosine arabinoside in newly diagnosed adult with Langerhans cell histiocytosis.

Detailed Description
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This single arm clinical trial is studying efficacy and tolerance of combination chemotherapy with methotrexate and cytosine arabinoside in newly diagnosed adult with Langerhans cell histiocytosis.

Official Title
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Efficacy and Tolerance of Combination Chemotherapy With Methotrexate and Cytosine Arabinoside in Newly Diagnosed Adult With Langerhans Cell Histiocytosis

Conditions
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Langerhans Cell Histiocytosis

Intervention / Treatment
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* Drug: methotrexate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.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) 1.No single-system lung involvement Multi-system low-risk disease 1.Multiple organs involved but without involvement of risk organs Single-system disease 1.Multifocal bone disease (i.e., lesions in 2 or more different bones) 2.Localized special site involvement, such as CNS-risk lesions with intracranial soft tissue extension or vertebral lesions with intraspinal soft tissue extension 3.Vault lesions are not regarded as CNS-risk lesions 2.PATIENT CHARACTERISTICS: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception 3.PRIOR CONCURRENT THERAPY: No prior treatment for Langerhans cell histiocytosis Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>methotrexate,1g/m2,iv.d1 cytosine arabinoside,0.1g/m2,iv.,d1-5 | Drug: methotrexate<br>* Single Group Assignment<br>* Other names: cytosine arabinoside;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | time from treatment to disease progression | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall free survival | time from treatment to die | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult with Langerhans cell histiocytosis, newly diagnosed, methotrexate, cytosine arabinoside