Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)
Information source: Memorial Sloan-Kettering Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hodgkin's Disease
Intervention: Methotrexate (Drug); Lecovorin calcium (Drug); 6-Thioguanine (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Memorial Sloan-Kettering Cancer Center Official(s) and/or principal investigator(s):
Tanya Trippett, MD, Principal Investigator, Affiliation: Memorial Sloan-Kettering Cancer Center/94-030
Summary
The objective of this study is to determine the incidence of complete and partial response
and the duration of respons in patients with recurrent or resistant hodgkin's disease (HD)
treated with sequential administration of oral 6-Thioguanin (6-TG) after IV Methotrexate
(MTX).
Clinical Details
Official title: Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)
Study design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Primary outcome: 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).
Secondary outcome: Define Toxicity of this sequential drug combination.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with histologic proof of HD who are in relapse and have failed >_ 2 prior
chemotherapy regimens.
- Patients must have a life expectancy of at least 8 weeks.
- All patients must have ECOG performance level rating of<_ 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 (bilimbin <_ 2. 0 mg/dl, SGOT less than 1. 5
times normal (unless it is due to disease), adequate renal function (creatinine _< 1. 5
mg/dl, creatinine clearance >_ 60 ml/min/1. 73 m2).
- Patients should have a granulocyte count >_500/gL and a platelet count >_ 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.
Locations and Contacts
Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States
Additional Information
Starting date: March 1994
Ending date: December 2008
Last updated: January 7, 2008
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