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

Hodgkin's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587873
• Other study ID #: 94-030
• Status: Completed
• Phase: Phase 2
• First received: December 26, 2007
• Last updated: June 10, 2009
• Start date: March 1994
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2009
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease

Intervention

Drug:
• Methotrexate
MTX 6mg/m2 given IV bolus, followed by 24mg/m2 given in 24hrs continuous infusion
• Leucovorin calcium
5 mg orally at 12 hours after the end of MTX infusion then every 12 hrs for a total of 3 doses.
• 6-Thioguanine
6-TG 300 mg/m2 PO as a single oral dose

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Conclusion of the study	No
Secondary	Define Toxicity of this sequential drug combination.		Conclusion of study	Yes

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