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

This is an interventional treatment trial for Langerhans Cell Histiocytosis focused on measuring Langerhans Cell Histiocytosis, LCH, 6-Thioguanine, 6-TG, Methotrexate, MTX, 94-132 Read More

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.