Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052403
Status:
WITHDRAWN
Last Update Posted:
2014-01-16
First Post:
2003-01-24
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase I Study of Monoclonal Antibody Anti-Anb3 Integrin in Patients With Advanced Solid Tumors
Status:
WITHDRAWN
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was not successful at recruiting particpants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and recommended phase II dose of monoclonal antibody anti-anb3 integrin in patients with advanced solid tumors
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
Determine the potential anti-tumor activity of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive monoclonal antibody anti-anb3 integrin IV over 30 minutes weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody anti-anb3 integrin 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 toxicity Once the MTD is determined additional patients are treated as above at that dose level
PROJECTED ACCRUAL A total of 27-33 patients will be accrued for this study within 9-11 months
Determine the maximum tolerated dose and recommended phase II dose of monoclonal antibody anti-anb3 integrin in patients with advanced solid tumors
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
Determine the potential anti-tumor activity of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive monoclonal antibody anti-anb3 integrin IV over 30 minutes weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody anti-anb3 integrin 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 toxicity Once the MTD is determined additional patients are treated as above at that dose level
PROJECTED ACCRUAL A total of 27-33 patients will be accrued for this study within 9-11 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 |
|---|---|---|---|
| NCI-5496 | None | None | None |
| WSU-C-2453 | None | None | None |