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

Study Overview
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Brief Summary
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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).

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

Conditions
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Hodgkin's Disease

Intervention / Treatment
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* Drug: Methotrexate
* Drug: Leucovorin calcium
* Drug: 6-Thioguanine


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MTX, 6-TG, and Leucovorin combination | Drug: Methotrexate<br>* MTX 6mg/m2 given IV bolus, followed by 24mg/m2 given in 24hrs continuous infusion<br>* Other names: MTX;Drug: Leucovorin calcium<br>* 5 mg orally at 12 hours after the end of MTX infusion then every 12 hrs for a total of 3 doses.<br>Drug: 6-Thioguanine<br>* 6-TG 300 mg/m2 PO as a single oral dose<br>* Other names: 6-TG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define Toxicity of this sequential drug combination. |  | Conclusion of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsed, Hodgkin's Disease, Methotrexate, 6-Thioguanine, 94-030