Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome|
- 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).
|Study Start Date:||May 1998|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004106
|United States, Connecticut|
|Yale Comprehensive Cancer Center at Yale University School of Medicine|
|New Haven, Connecticut, United States, 06520-8028|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Study Chair:||Timothy M. Kuzel, MD||Robert H. Lurie Cancer Center|