Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome
- 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
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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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).
After every 2 cycles of therapy
Timothy M. Kuzel, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Yale Comprehensive Cancer Center at Yale University School of Medicine||New Haven, Connecticut 06520-8064|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|