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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Temozolomid will be administered orally at a dose of 150mg/m2/day for 5 days for a total of 4 weeks
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, Connecticut, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Response rate
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).
Time frame: After every 2 cycles of therapy
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