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

This study is ongoing, but not recruiting participants.

Sponsored by: 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 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).


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

MedlinePlus related topics:   Cancer    Hodgkin's Disease   

ChemIDplus related topics:   Methotrexate    Calcium gluconate    Thioguanine   

U.S. FDA Resources

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)

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 ]

Estimated Enrollment:   30
Study Start Date:   March 1994
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (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: Lecovorin calcium
5 mg orally at 12 hours after the end of MTX infusion then evervy 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 >_ 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.
  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


Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Memorial Sloan-Kettering cance Center ( Tanya Trippett, MD )
Study ID Numbers:   94-030
First Received:   December 26, 2007
Last Updated:   January 7, 2008
ClinicalTrials.gov Identifier:   NCT00587873
Health Authority:   United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Relapsed  
Hodgkin's Disease  
Methotrexate  
6-Thioguanine  
94-030  

Study placed in the following topic categories:
Folic Acid
Lymphatic Diseases
Hodgkin's disease
Immunoproliferative Disorders
Hodgkin lymphoma, adult
Thioguanine
Methotrexate
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease

Additional relevant MeSH terms:
Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 03, 2008




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