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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00587873 |
The objective of this study is to determine the incidence of complete and partial response and the duration of respons in patients with recurrent or resistant hodgkin's disease (HD) treated with sequential administration of oral 6-Thioguanin (6-TG) after IV Methotrexate (MTX).
Condition | Intervention | Phase |
Hodgkin's Disease |
Drug: Methotrexate Drug: Lecovorin calcium Drug: 6-Thioguanine |
Phase II |
MedlinePlus related topics: | Cancer Hodgkin's Disease |
ChemIDplus related topics: | Methotrexate Calcium gluconate Thioguanine |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II) |
Estimated Enrollment: | 30 |
Study Start Date: | March 1994 |
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, and Leucovorin combination
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Drug: Methotrexate
MTX 6mg/m2 given IV bolus, followed by 24mg/m2 given in 24hrs continuous infusion
Drug: Lecovorin calcium
5 mg orally at 12 hours after the end of MTX infusion then evervy 12 hrs for a total of 3 doses.
Drug: 6-Thioguanine
6-TG 300 mg/m2 PO as a single oral dose
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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 |
Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Tanya Trippett, MD | Memorial Sloan-Kettering Cancer Center/94-030 |
Related Info 
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Responsible Party: | Memorial Sloan-Kettering cance Center ( Tanya Trippett, MD ) |
Study ID Numbers: | 94-030 |
First Received: | December 26, 2007 |
Last Updated: | January 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00587873 |
Health Authority: | United States: Institutional Review Board |
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