Hodgkin's Disease
Conditions
Keywords
Relapsed, Hodgkin's Disease, Methotrexate, 6-Thioguanine, 94-030
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).
Interventions
DRUGMethotrexate
MTX 6mg/m2 given IV bolus, followed by 24mg/m2 given in 24hrs continuous infusion
DRUGLeucovorin calcium
5 mg orally at 12 hours after the end of MTX infusion then every 12 hrs for a total of 3 doses.
DRUG6-Thioguanine
6-TG 300 mg/m2 PO as a single oral dose
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Define Toxicity of this sequential drug combination. | Conclusion of study |
Countries
United States
Outcome results
None listed