Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
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|ClinicalTrials.gov Identifier: NCT00004106|
Recruitment Status : Terminated (Per Data Monitoring Committee given the poor/inadequate accrual.)
First Posted : January 27, 2003
Last Update Posted : June 6, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: temozolomide||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome|
|Study Start Date :||May 1998|
|Actual Primary Completion Date :||April 2006|
|Actual Study Completion Date :||April 2006|
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|