Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086723
Status:
COMPLETED
Last Update Posted:
2012-06-11
First Post:
2004-07-08
Brief Title:
In Vivo Angiostatin Generation Using Tissue Plasminogen Activator and Captopril in Treating Patients With Progressive Metastatic Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase III Trial of In Vivo Angiostatin Generation With Tissue Plasminogen Activator tPA and Captopril in Patients With Progressive Metastatic Cancer
Status:
COMPLETED
Status Verified Date:
2012-06
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 Tissue plasminogen activator and captopril may help the body generate angiostatin Angiostatin may stop the growth of cancer by stopping blood flow to the tumor
PURPOSE This phase III trial is studying the side effects and best dose of tissue plasminogen activator and captopril and to see how well they work in treating patients with progressive metastatic cancer
PURPOSE This phase III trial is studying the side effects and best dose of tissue plasminogen activator and captopril and to see how well they work in treating patients with progressive metastatic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and toxicity of captopril and tissue plasminogen activator tPA in patients with progressive metastatic cancer
Determine the in vivo generation of angiostatin by western analysis in patients treated with this regimen
Secondary
Determine the antitumor effect of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive tissue plasminogen activator tPA IV over 6 hours and oral captopril twice daily on days 1-5 Courses repeat every 14 days for up to 1 year in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 2 additional courses beyond CR
Cohorts of 3-6 patients receive escalating doses of tPA and captopril until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Not specified
Primary
Determine the maximum tolerated dose and toxicity of captopril and tissue plasminogen activator tPA in patients with progressive metastatic cancer
Determine the in vivo generation of angiostatin by western analysis in patients treated with this regimen
Secondary
Determine the antitumor effect of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive tissue plasminogen activator tPA IV over 6 hours and oral captopril twice daily on days 1-5 Courses repeat every 14 days for up to 1 year in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 2 additional courses beyond CR
Cohorts of 3-6 patients receive escalating doses of tPA and captopril until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Not specified
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 |
|---|---|---|---|
| NU-NCI-00B9 | None | None | None |