Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT00004106
Status:
TERMINATED
Last Update Posted:
2012-06-06
First Post:
1999-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Per Data Monitoring Committee given the poor/inadequate accrual.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Description:
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.
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: