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

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00587873

Purpose

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	Intervention	Phase
Hodgkin's Disease	Drug: Methotrexate Drug: Leucovorin calcium Drug: 6-Thioguanine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin Disease

Drug Information available for: Leucovorin Methotrexate Citrovorum factor Thioguanine Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

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). [ Time Frame: Conclusion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Define Toxicity of this sequential drug combination. [ Time Frame: Conclusion of study ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	March 1994
Study Completion Date:	June 2009
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MTX, 6-TG, and Leucovorin combination	Drug: Methotrexate MTX 6mg/m2 given IV bolus, followed by 24mg/m2 given in 24hrs continuous infusion 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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587873

Locations

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Tanya Trippett, MD

Memorial Sloan-Kettering Cancer Center/94-030

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering cance Center ( Tanya Trippett, MD )
Study ID Numbers:	94-030
Study First Received:	December 26, 2007
Last Updated:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00587873 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Relapsed
Hodgkin's Disease
Methotrexate
6-Thioguanine
94-030

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Leucovorin
6-Mercaptopurine
Reproductive Control Agents
Vitamins
Therapeutic Uses
Abortifacient Agents
Methotrexate
Micronutrients
Dermatologic Agents

Lymphoma
Hodgkin Disease
Nucleic Acid Synthesis Inhibitors
Vitamin B Complex
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Growth Substances
Thioguanine
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases

ClinicalTrials.gov processed this record on November 27, 2009