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

Phase 2

Completed

• Conditions: Hodgkin's Disease
• Interventions: Drug: Methotrexate; Drug: Leucovorin calcium; Drug: 6-Thioguanine

• Registration Number: NCT00587873
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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

Not available

Study Timeline

• Study Start: 1994-03
• Primary Completion: 2003-12
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-07
• Study First Posted: 2008-01-08
• Status Verified: 2009-06
• Study Completion: 2009-06
• Last Update Submitted: 2009-06-10
• Last Update Posted: 2009-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Leucovorin calcium	MTX, 6-TG, and Leucovorin combination
1	Methotrexate	MTX, 6-TG, and Leucovorin combination
1	6-Thioguanine	MTX, 6-TG, and Leucovorin combination

Primary Outcome Measures

Name	Time	Method
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).	Conclusion of the study

Secondary Outcome Measures

Name	Time	Method
Define Toxicity of this sequential drug combination.	Conclusion of study

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States