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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00588536 |
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 |
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Langerhans Cell Histiocytosis |
Drug: Methotrexate Drug: 6-Thioguanine Drug: Leucovorin Calcium |
Phase II |
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) |
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 |
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1: Experimental
MTX, 6-TG, Leucovorin
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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)
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Tanya Trippett, MD | Memorial Sloan-Kettering Cancer Center |
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 |
Langerhans Cell Histiocytosis LCH 6-Thioguanine 6-TG |
Methotrexate MTX 94-132 |
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 |
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 |