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

Primary Purpose

Hodgkin's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methotrexate
Leucovorin calcium
6-Thioguanine
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin's Disease focused on measuring Relapsed, Hodgkin's Disease, Methotrexate, 6-Thioguanine, 94-030

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

MTX, 6-TG, and Leucovorin combination

Outcomes

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).

Secondary Outcome Measures

Define Toxicity of this sequential drug combination.

Full Information

First Posted
December 26, 2007
Last Updated
June 10, 2009
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00587873
Brief Title
Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)
Official Title
Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
March 1994 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Disease
Keywords
Relapsed, Hodgkin's Disease, Methotrexate, 6-Thioguanine, 94-030

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
MTX, 6-TG, and Leucovorin combination
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
MTX
Intervention Description
MTX 6mg/m2 given IV bolus, followed by 24mg/m2 given in 24hrs continuous infusion
Intervention Type
Drug
Intervention Name(s)
Leucovorin calcium
Intervention Description
5 mg orally at 12 hours after the end of MTX infusion then every 12 hrs for a total of 3 doses.
Intervention Type
Drug
Intervention Name(s)
6-Thioguanine
Other Intervention Name(s)
6-TG
Intervention Description
6-TG 300 mg/m2 PO as a single oral dose
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Define Toxicity of this sequential drug combination.
Time Frame
Conclusion of study

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya Trippett, MD
Organizational Affiliation
Memorial Sloan-Kettering Cancer Center/94-030
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Related Info

Learn more about this trial

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

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