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

December 26, 2007
June 10, 2009
March 1994
December 2003   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00587873 on ClinicalTrials.gov Archive Site
Define Toxicity of this sequential drug combination. [ Time Frame: Conclusion of study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)
Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)

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).

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hodgkin's Disease
  • 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
Experimental: 1
MTX, 6-TG, and Leucovorin combination
Interventions:
  • Drug: Methotrexate
  • Drug: Leucovorin calcium
  • Drug: 6-Thioguanine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
June 2009
December 2003   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587873
94-030
Not Provided
Tanya Trippett, MD, Memorial Sloan-Kettering cance Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Tanya Trippett, MD Memorial Sloan-Kettering Cancer Center/94-030
Memorial Sloan-Kettering Cancer Center
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP