Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033709
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2002-04-09
Brief Title:
Temozolomide and Thalidomide in Treating Patients With Metastatic Locally Advanced or Unresectable Leiomyosarcoma
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Combination Therapy of a Protracted Oral Schedule of Temozolomide and Thalidomide as First-Line or Subsequent Therapy for Patients With Metastatic Locally Advanced or Unresectable Leiomyosarcoma
Status:
UNKNOWN
Status Verified Date:
2005-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 tumor cells from dividing so they stop growing or die Thalidomide may stop the growth of cancer by stopping blood flow to the tumor Combining temozolomide with thalidomide may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining temozolomide with thalidomide in treating patients who have metastatic locally advanced or unresectable leiomyosarcoma
PURPOSE Phase II trial to study the effectiveness of combining temozolomide with thalidomide in treating patients who have metastatic locally advanced or unresectable leiomyosarcoma
Detailed Description:
OBJECTIVES
Determine the efficacy of temozolomide and thalidomide in patients with metastatic locally advanced or unresectable leiomyosarcoma
Determine the time to progression in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the clinical and laboratory toxic effects and tolerability of this regimen in these patients
OUTLINE Patients receive oral temozolomide once daily for 7 days every other week and oral thalidomide once daily Treatment continues for up to 26 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study within 75-25 months
Determine the efficacy of temozolomide and thalidomide in patients with metastatic locally advanced or unresectable leiomyosarcoma
Determine the time to progression in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the clinical and laboratory toxic effects and tolerability of this regimen in these patients
OUTLINE Patients receive oral temozolomide once daily for 7 days every other week and oral thalidomide once daily Treatment continues for up to 26 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study within 75-25 months
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G02-2060 | None | None | None |
| CPMC-IRB-14323 | None | None | None |