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

Completed · Phase 2

Conditions studied: Langerhans Cell Histiocytosis

In brief

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).

Key facts

Study ID

NCT00588536

Run by

Memorial Sloan Kettering Cancer Center

People needed

5

Starts

1995-01-01

Expected to finish

2009-06-01

Last updated by the study team

2015-05-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients with active infections or significant medical conditions other than their disease (LCH) shall be excluded.

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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