Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II) - Tabular View

Tracking Information

First Received Date ^ICMJE

December 26, 2007

Last Updated Date

June 10, 2009

Start Date ^ICMJE

March 1994

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine the incidence of complete and partial response and the duration of response in patients with recurrent or resistant Hodgkin's Disease (HD) treated with sequential administration of oral 6-Thioguanine (6-TG) after IV Methotrexate (MTX). [ Time Frame: Conclusion of the study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00587873 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Define Toxicity of this sequential drug combination. [ Time Frame: Conclusion of study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)

Official Title ^ICMJE

Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)

Brief Summary

The objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with recurrent or resistant Hodgkin's disease (HD) treated with sequential administration of oral 6-Thioguanin (6-TG) after IV Methotrexate (MTX).

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Hodgkin's Disease

Intervention ^ICMJE

Drug: Methotrexate
Drug: Leucovorin calcium
Drug: 6-Thioguanine

Study Arms / Comparison Groups

Experimental: MTX, 6-TG, and Leucovorin combination

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with histologic proof of HD who are in relapse and have failed > or = to 2 prior chemotherapy regimens.
Patients must have a life expectancy of at least 8 weeks.
All patients must have ECOG performance level rating of < or = to 2.
Patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study.
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 CT.
Patients must have adequate liver function (bilirubin < or = to 2.0 mg/dl, SGOT less than 1.5 times normal (unless it is due to disease), adequate renal function (creatinine < or = to 1.5 mg/dl, creatinine clearance > or = to 60 ml/min/1.73 m2).
Patients should have a granulocyte count > or = to 500/gL and a platelet count > or = to 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 malignancy shall be excluded.
Patients with HD who had prior MTX or 6-TG should be excluded.

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00587873

Responsible Party

Tanya Trippett, MD, Memorial Sloan-Kettering cance Center

Study ID Numbers ^ICMJE

94-030

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Tanya Trippett, MD

Memorial Sloan-Kettering Cancer Center/94-030

Information Provided By

Memorial Sloan-Kettering Cancer Center

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP