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

Langerhans Cell Histiocytosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588536
• Other study ID #: 94-132
• Status: Completed
• Phase: Phase 2
• First received: December 26, 2007
• Last updated: April 16, 2015
• Start date: January 1995
• Est. completion date: June 2009

Study information

• Verified date: April 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Histiocytosis
• Histiocytosis, Langerhans-Cell
• Langerhans Cell Histiocytosis

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Conclusion of the study	No

External Links

•   Memorial Sloan-Kettering Cancer Center