Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
---|---|
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 |
---|---|---|
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 |
---|---|
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)
|
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 History of Changes |
Health Authority: | United States: Institutional Review Board |
Langerhans Cell Histiocytosis LCH 6-Thioguanine 6-TG |
Methotrexate MTX 94-132 |
Antimetabolites Langerhans Cell Histiocytosis Lung Diseases, Interstitial Letterer-Siwe Disease Vitamin B Complex Immunologic Factors Thioguanine Leucovorin Trace Elements 6-Mercaptopurine Folic Acid Antagonists Histiocytosis, Langerhans-Cell |
Immunosuppressive Agents Histiocytosis X Folic Acid Lymphatic Diseases Calcium, Dietary Histiocytosis Respiratory Tract Diseases Vitamins Lung Diseases Methotrexate Micronutrients Antirheumatic Agents |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leucovorin 6-Mercaptopurine Reproductive Control Agents Respiratory Tract Diseases Histiocytosis Vitamins Therapeutic Uses Abortifacient Agents Methotrexate |
Micronutrients Dermatologic Agents Nucleic Acid Synthesis Inhibitors Lung Diseases, Interstitial Vitamin B Complex Reticuloendotheliosis Growth Substances Thioguanine Enzyme Inhibitors Folic Acid Antagonists Histiocytosis, Langerhans-Cell Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases |