Clinical Trial: Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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.


Detailed Summary:

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.


Sponsor: Northwestern University

Current Primary Outcome: Response rate [ Time Frame: After every 2 cycles of therapy ]

Disease response will be assessed using bi-dimensional measurements of lesions with clearly defined margins by medical photograph (skin lesion) or by radiological imaging (internal lesions).


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Northwestern University

Dates:
Date Received: December 10, 1999
Date Started: May 1998
Date Completion:
Last Updated: May 31, 2012
Last Verified: May 2012