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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-03-31

Study Completion Date

2009-06-30

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).

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Detailed Description

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Conditions

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Hodgkin's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

MTX, 6-TG, and Leucovorin combination

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

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

Leucovorin calcium

Intervention Type DRUG

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

6-Thioguanine

Intervention Type DRUG

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

Interventions

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Methotrexate

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

Intervention Type 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.

Intervention Type DRUG

6-Thioguanine

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

Intervention Type DRUG

Other Intervention Names

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MTX 6-TG

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No