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

April 16, 2015 updated by: Memorial Sloan Kettering Cancer Center

Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With Langerhans Cell in Histiocytosis (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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
MTX, 6-TG, Leucovorin
Drug: Methotrexate
MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs
Other Names:
  • MTX
Drug: 6-Thioguanine
6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.
Other Names:
  • 6-TG
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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-TG After MTX.
Time Frame: Conclusion of the study
Conclusion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1995

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 7, 2008

First Posted (Estimate)

January 8, 2008

Study Record Updates

Last Update Posted (Estimate)

May 4, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 94-132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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