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