Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006005
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2000-07-05
Brief Title:
Thalidomide in Treating Patients With Gynecologic Sarcomas
Sponsor:
New York University Cancer Institute
Organization:
National Cancer Institute NCI
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NYOG-0102-073 | None | None | None |
| NYGOG-99-001 | None | None | None |
| NCI-314 | None | None | None |