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

Phase 2
Not Enrolling
Hodgkin's Disease

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

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

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).

Outcome Time Frame:

Conclusion of the study

Safety Issue:


Principal Investigator

Tanya Trippett, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center/94-030


United States: Institutional Review Board

Study ID:




Start Date:

March 1994

Completion Date:

June 2009

Related Keywords:

  • Hodgkin's Disease
  • Relapsed
  • Hodgkin's Disease
  • Methotrexate
  • 6-Thioguanine
  • 94-030
  • Hodgkin Disease



Memorial Sloan Kettering Cancer CenterNew York, New York  10021