Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT00006005
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2000-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thalidomide in Treating Patients With Gynecologic Sarcomas
Sponsor:
New York University Cancer Institute
Organization:
Study Overview
Official Title:
Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin
Status:
COMPLETED
Status Verified Date:
2004-08
Last Known Status:
None
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: Thalidomide may stop the growth of gynecologic sarcomas by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent gynecologic sarcomas.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent gynecologic sarcomas.
Detailed Description:
OBJECTIVES:
* Determine the impact on survival and the antitumor effects of thalidomide in patients with sarcomas or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin.
* Determine the safety and side effect profiles of the target dose of this treatment regimen in this patient population.
* Determine the antiangiogenic and immunologic effects of this treatment regimen in these patients.
OUTLINE: Patients receive oral thalidomide daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 18 months.
* Determine the impact on survival and the antitumor effects of thalidomide in patients with sarcomas or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin.
* Determine the safety and side effect profiles of the target dose of this treatment regimen in this patient population.
* Determine the antiangiogenic and immunologic effects of this treatment regimen in these patients.
OUTLINE: Patients receive oral thalidomide daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 18 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?: