Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT00025220
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2001-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
Status:
COMPLETED
Status Verified Date:
2019-07
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:
Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent cancer of the uterus. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the antitumor cytostatic activity of thalidomide, as measured by the probability of progression-free survival (PFS) for at least 6 months, in patients with recurrent or persistent uterine leiomyosarcoma.
II. Determine the nature and degree of the toxicity of this drug in these patients.
III. Determine the partial and complete response rates in patients treated with this drug.
IV. Determine the duration of PFS and overall survival of patients treated with this drug.
V. Determine the effect of this drug on initial performance status in these patients.
VI. Determine the effects of this drug at 4 weeks on endogenous angiogenesis factors (vascular endothelial growth factor and basic fibroblast growth factor) in plasma and urine of these patients.
VII. Assess the association of endogenous angiogenesis factors with clinical outcome (PFS) in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks 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.
I. Determine the antitumor cytostatic activity of thalidomide, as measured by the probability of progression-free survival (PFS) for at least 6 months, in patients with recurrent or persistent uterine leiomyosarcoma.
II. Determine the nature and degree of the toxicity of this drug in these patients.
III. Determine the partial and complete response rates in patients treated with this drug.
IV. Determine the duration of PFS and overall survival of patients treated with this drug.
V. Determine the effect of this drug on initial performance status in these patients.
VI. Determine the effects of this drug at 4 weeks on endogenous angiogenesis factors (vascular endothelial growth factor and basic fibroblast growth factor) in plasma and urine of these patients.
VII. Assess the association of endogenous angiogenesis factors with clinical outcome (PFS) in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks 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.
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?: