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

NCT00588536 | Completed Phase 2 Results

• 1 other identifier: 94-132
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Langerhans Cell Histiocytosis; LCH; 6-Thioguanine; 6-TG; Methotrexate; MTX; 94-132

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

MTX, 6-TG, Leucovorin

Drug: Methotrexate; Drug: 6-Thioguanine; Drug: Leucovorin Calcium

Interventions

Methotrexate DRUG

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

Also known as: MTX

1

6-Thioguanine DRUG

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

Also known as: 6-TG

1

Leucovorin Calcium DRUG

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)

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with active infections or significant medical conditions other than their disease (LCH) shall be excluded.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Histiocytosis, Langerhans-Cell

Interventions

Methotrexate; Thioguanine; Leucovorin

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Purines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Coenzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Dr. Tanya Trippett
• Organization: Memorial Sloan Kettering Cancer Center

trippet1@mskcc.org

212-639-8267

Study Officials

• Tanya Trippett, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 8, 2008
• Study Start: January 1, 1995
• Primary Completion: July 1, 2008
• Study Completion: June 1, 2009
• Last Updated: May 4, 2015
• Results First Posted: May 4, 2015

Record last verified: 2015-04

Locations

US (1)