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

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00587873
First received: December 26, 2007
Last updated: June 10, 2009
Last verified: June 2009
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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

  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
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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:
No publications provided

Responsible Party: Tanya Trippett, MD, Memorial Sloan-Kettering cance Center
ClinicalTrials.gov Identifier: NCT00587873     History of Changes
Other Study ID Numbers: 94-030
Study First Received: December 26, 2007
Last Updated: June 10, 2009
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:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Methotrexate
Thioguanine
Levoleucovorin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on September 16, 2014