Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006014
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
2000-07-05
Brief Title:
SU5416 in Treating Patients With Malignant Mesothelioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of SU5416 NSC 696819 in Patients With Malignant Mesothelioma
Status:
COMPLETED
Status Verified Date:
2009-02
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 SU5416 in treating patients who have malignant mesothelioma SU5416 may stop the growth of malignant mesothelioma by stopping blood flow to the tumor
Detailed Description:
OBJECTIVES
I Determine the objective response rate median and overall survival and time to progression in patients with unresectable malignant mesothelioma treated with SU5416
II Determine the effect of SU5416 on surrogate biologic endpoints including microvessel density tissue proliferative index apoptosis vascular endothelial growth factor levels and tumor perfusion measured by MRI in these patients
III Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive SU5416 IV over 1 hour twice weekly Courses repeat every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 21-45 patients will be accrued for this study within 18-24 months
I Determine the objective response rate median and overall survival and time to progression in patients with unresectable malignant mesothelioma treated with SU5416
II Determine the effect of SU5416 on surrogate biologic endpoints including microvessel density tissue proliferative index apoptosis vascular endothelial growth factor levels and tumor perfusion measured by MRI in these patients
III Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive SU5416 IV over 1 hour twice weekly Courses repeat every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 21-45 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 |
|---|---|---|---|
| CDR0000068023 | REGISTRY | PDQ Physician Data Query | None |
| UCCRC-10409 | None | None | None |
| UCCRC-NCI-44 | None | None | None |
| NCI-44 | None | None | None |