Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060242
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2003-05-06
Brief Title:
Combretastatin A4 Phosphate in Treating Patients With Advanced Anaplastic Thyroid Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial Of Combretastatin A-4 Phosphate CA4P In Advanced Anaplastic Carcinoma Of The Thyroid
Status:
COMPLETED
Status Verified Date:
2010-06
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 Combretastatin A4 phosphate may stop the growth of anaplastic thyroid cancer by stopping blood flow to the tumor
PURPOSE This phase II trial is studying how well combretastatin A4 phosphate works in treating patients with advanced recurrent or metastatic anaplastic thyroid cancer
PURPOSE This phase II trial is studying how well combretastatin A4 phosphate works in treating patients with advanced recurrent or metastatic anaplastic thyroid cancer
Detailed Description:
OBJECTIVES
Determine the objective response rate of patients with advanced anaplastic thyroid cancer treated with combretastatin A4 phosphate
Determine whether this drug alters the natural history of anaplastic thyroid cancer in terms of doubling the median survival from 4-6 months to 12 months in these patients
Determine the safety profile of this drug in these patients
Correlate clinical response with pretreatment tumor microvessel density and immature vessel staining changes in sICAM-1 levels over the course of treatment and pharmacokinetic parameters in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive combretastatin A4 phosphate IV over 10 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 courses beyond documentation of the CR
Patients are followed monthly
PROJECTED ACCRUAL A total of 32 patients will be accrued for this study within 18-24 months
Determine the objective response rate of patients with advanced anaplastic thyroid cancer treated with combretastatin A4 phosphate
Determine whether this drug alters the natural history of anaplastic thyroid cancer in terms of doubling the median survival from 4-6 months to 12 months in these patients
Determine the safety profile of this drug in these patients
Correlate clinical response with pretreatment tumor microvessel density and immature vessel staining changes in sICAM-1 levels over the course of treatment and pharmacokinetic parameters in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive combretastatin A4 phosphate IV over 10 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 courses beyond documentation of the CR
Patients are followed monthly
PROJECTED ACCRUAL A total of 32 patients will be accrued for this study within 18-24 months
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 |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE-CWRU-ICC-2302 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |