NCT00588536

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 Langerhans Cell in Histiocytosis (LCH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Langerhans Cell Histiocytosis

Interventions

Type	Name	Description
DRUG	Methotrexate	MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs
DRUG	6-Thioguanine	6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.
DRUG	Leucovorin Calcium	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)

Timeline

• Start date: 1995-01-01
• Primary completion: 2008-07-01
• Completion: 2009-06-01
• First posted: 2008-01-08
• Last updated: 2015-05-04
• Results posted: 2015-05-04

Locations

1 site across 1 country: United States