Official Title: “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 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).

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • MTX, 6-TG, and Leucovorin combination

Primary 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
    Safety Issue?: No

Secondary Measures

• Define Toxicity of this sequential drug combination.
  • Time Frame: Conclusion of study
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Memorial Sloan-Kettering Cancer Center

Overall Clinical Trial Officials and Contacts

Tanya Trippett, MD Principal Investigator Memorial Sloan-Kettering Cancer Center/94-030  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00587873

Study ID Number: 94-030

ClinicalTrials.gov Identifier: NCT00587873

Health Authority: United States: Institutional Review Board