Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004106
Status:
TERMINATED
Last Update Posted:
2012-06-06
First Post:
1999-12-10
Brief Title:
Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
Sponsor:
Northwestern University
Organization:
Northwestern University
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 poorinadequate 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NU-FDA97H3 | None | None | None |
| NCI-G99-1597 | None | None | None |
| STU00010001 | OTHER | Northwestern University IRB | None |