Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With LCH
NCT ID: NCT00588536
Last Updated: 2015-05-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
5 participants
INTERVENTIONAL
1995-01-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
MTX, 6-TG, Leucovorin
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Tanya Trippett, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan-Kettering Cancer Center
Other Identifiers
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94-132
Identifier Type: -
Identifier Source: org_study_id
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