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

NCT00588536 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2015-05-04

Study results available
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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

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)

Sponsors & Collaborators

Principal Investigators

  • Tanya Trippett, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-01-31
Primary Completion
2008-07-31
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00588536 on ClinicalTrials.gov