CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 5 enrolled
Drug / intervention
Methotrexate +2 moredrug
Likely dose
Methotrexate 30mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00588536
NCT00588536Phase 2Completed
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Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With Langerhans Cell in Histiocytosis (LCH)

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 8, 2008·Updated May 4, 2015

In Brief

A Phase 2 clinical trial evaluating Methotrexate, 6-Thioguanine, and 1 other intervention for Langerhans Cell Histiocytosis. Completed, enrolled 5 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLangerhans Cell Histiocytosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 8, 2008
Enrollment StartJan 1, 1995
Primary CompletionJul 1, 2008
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 13.5 yearsPosted 18.5 years ago

Interventions

Methotrexatedrug

MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs

6-Thioguaninedrug

6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.

Leucovorin Calciumdrug

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)