Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome

Lymphoma Clinical Trial

Official title: Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome

Status Terminated

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying temozolomide to see how well it works in treating patients with mycosis fungoides or Sezary syndrome that has not responded to previous treatment.

Clinical Trial Description

OBJECTIVES:

• Determine the response rate to temozolomide in patients with relapsed mycosis fungoides or Sezary syndrome.

• Determine the toxic effects of this drug in these patients.

• Correlate pretreatment AGT activity in tumor cells with response to this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity for a maximum of 1 year.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2 years. ;

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Mycoses
• Mycosis Fungoides
• Sezary Syndrome

• NCT number: NCT00004106
• Study type: Interventional
• Source: Northwestern University
• Status: Terminated
• Phase: Phase 2
• Start date: May 1998
• Completion date: April 2006