Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004872
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2000-03-07
Brief Title:
Endostatin in Treating Patients With Advanced Refractory Solid Tumors
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Phase I Study of Endostatin in Advanced Cancer Patients
Status:
COMPLETED
Status Verified Date:
2015-09
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 Endostatin may stop the growth of solid tumors by stopping blood flow to the tumor
PURPOSE Phase I trial to study the effectiveness of endostatin in treating patients who have advanced refractory solid tumors
PURPOSE Phase I trial to study the effectiveness of endostatin in treating patients who have advanced refractory solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD and Phase II dose of endostatin in patients with advanced refractory solid tumors II Determine the qualitative and quantitative nature of the toxicities encountered with endostatin in this patient population III Evaluate the basic pharmacokinetics and metabolism of endostatin by measurement of plasma levels by EIA and mass spectrometry in this patient population IV Investigate the relationship between pharmacokinetic parameters and toxicity in this patient population V Evaluate biologic evidence of angiogenesis inhibition in patients receiving endostatin
OUTLINE This is a dose escalation study Patients receive endostatin IV over 1 hour daily for 28 days followed by 1 week of rest Patients receive subsequent courses of daily therapy in the absence of disease progression or unacceptable toxicity Cohorts of 3 patients receive escalating doses of endostatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities
PROJECTED ACCRUAL Approximately 30-40 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive endostatin IV over 1 hour daily for 28 days followed by 1 week of rest Patients receive subsequent courses of daily therapy in the absence of disease progression or unacceptable toxicity Cohorts of 3 patients receive escalating doses of endostatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities
PROJECTED ACCRUAL Approximately 30-40 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-T99-0055 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA014520 |
| P30CA014520 | NIH | None | None |
| WCCC-CO-99910 | None | None | None |