Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With LCH

Study Overview
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Brief Summary
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The objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with Langerhans Cell Histiocytosis (LCH) treated with sequential administration of oral 6-Thioguanine (6-TG) after Methotrexate (MTX).

Official Title
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Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With Langerhans Cell in Histiocytosis (LCH)

Conditions
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Langerhans Cell Histiocytosis

Intervention / Treatment
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* Drug: Methotrexate
* Drug: 6-Thioguanine
* Drug: Leucovorin Calcium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologic proof of LCH who have multifocal or multisystem disease involvement. Patients must have a life expectancy of at least 8 weeks. All patients must have ECOG performance level rating of-< 2. Patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study, using commercially available drugs. Patients must have recovered from the toxic effects of prior therapy before entering this study or at least 2 weeks should have elapsed since the end of last course of chemotherapy. Patients must have adequate liver function (bilirubin _< 2.0 mg/dl, SGOT less than 1.5 times normal (unless it is due to disease), adequate renal function (creatinine <_ 1.5 mg/dl, creatinine clearance >_ 60 ml/min/1.73 m2) and normal electrolytes. Patients should have a granulocyte count > 500/uL and a platelet count >_ 100,000/uL (unless due to disease involvement of the bone marrow). Male and female patients of child-bearing age should use effective methods of contraception, if sexually active. Exclusion Criteria: Patients with active infections or significant medical conditions other than their disease (LCH) shall be excluded.
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: 1<br>MTX, 6-TG, Leucovorin | Drug: Methotrexate<br>* MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs<br>* Other names: MTX;Drug: 6-Thioguanine<br>* 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.<br>* Other names: 6-TG;Drug: Leucovorin Calcium<br>* 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the Incidence of Complete and Partial Response and the Duration of Response in Patients With Langerhans Cell Histiocytosis (LCH) Treated With Sequential Administration of Oral 6-TG After MTX. |  | Conclusion of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Langerhans Cell Histiocytosis, LCH, 6-Thioguanine, 6-TG, Methotrexate, MTX, 94-132