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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00587873

Collaborator

(none)

Enrollment

Location

Arm

183

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hodgkin's Disease	Drug: Methotrexate Drug: Leucovorin calcium Drug: 6-Thioguanine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 1994

Actual Primary Completion Date :

Dec 1, 2003

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

MTX, 6-TG, and Leucovorin combination

Drug: Methotrexate

MTX 6mg/m2 given IV bolus, followed by 24mg/m2 given in 24hrs continuous infusion

Other Names:

MTX

Drug: Leucovorin calcium

5 mg orally at 12 hours after the end of MTX infusion then every 12 hrs for a total of 3 doses.

Drug: 6-Thioguanine

6-TG 300 mg/m2 PO as a single oral dose

Other Names:

6-TG

Outcome Measures

Primary Outcome Measures

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

Define Toxicity of this sequential drug combination. [Conclusion of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.