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

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00588536

Purpose

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).

Condition	Intervention	Phase
Langerhans Cell Histiocytosis	Drug: Methotrexate Drug: 6-Thioguanine Drug: Leucovorin Calcium	Phase II

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Methotrexate Calcium gluconate Thioguanine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With Langerhans Cell in Histiocytosis (LCH)

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

Determine the incidence of complete and partial response and the duration of response in patients wit hLangerhans Cell Histiocytosis (LCH) treated with sequential administration of oral 6-TG after MTX. [ Time Frame: Conclusion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Define the toxicity of this sequential drug combination as defined by NCI Common Toxicity Criteria. [ Time Frame: Conclusion of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	January 1995
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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 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)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588536

Locations

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

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Tanya Trippett, MD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Tanya Trippett, MD )
Study ID Numbers:	94-132
Study First Received:	December 26, 2007
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00588536
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Langerhans Cell Histiocytosis
LCH
6-Thioguanine
6-TG

Methotrexate
MTX
94-132

Study placed in the following topic categories:

Lung Diseases, Interstitial
Thioguanine
Leucovorin
6-Mercaptopurine
Langerhans cell histiocytosis
Histiocytosis, Langerhans-Cell
Histiocytosis X
Folic Acid

Lymphatic Diseases
Calcium, Dietary
Letterer-Siwe disease
Histiocytosis
Respiratory Tract Diseases
Lung Diseases
Methotrexate

Additional relevant MeSH terms:

Antimetabolites
Reticuloendotheliosis
Vitamin B Complex
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Vitamins
Therapeutic Uses
Abortifacient Agents
Micronutrients
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009