Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049712
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2002-11-12
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Refractory Advanced Solid Tumors or Lymphoma
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
A Phase I Study Of Medi 522 In Patients With Advanced Tumors
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-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 refractory advanced solid tumors or lymphoma
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have refractory advanced solid tumors or lymphoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of monoclonal antibody anti-alpha V beta 3 integrin MEDI 522 in patients with refractory advanced solid tumors or lymphoma
Determine the safety and tolerability of this drug in these patients
Demonstrate significant binding of this drug to its molecular target in vivo in these patients
Determine the effects of this drug on angiogenesis in these patients
Determine antitumor activity of this drug by measuring tumor size and glucose uptake in these patients
Determine the pharmacokinetics of this drug in these patients
Determine a recommended phase II dose of this drug based on either the MTD or the optimal biologic response in these patients
OUTLINE This is a dose-escalation study
Patients receive monoclonal antibody anti-alpha V beta 3 integrin Medi 522 IV over 30 minutes weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of Medi 522 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 6-30 patients will be accrued for this study
Determine the maximum tolerated dose MTD of monoclonal antibody anti-alpha V beta 3 integrin MEDI 522 in patients with refractory advanced solid tumors or lymphoma
Determine the safety and tolerability of this drug in these patients
Demonstrate significant binding of this drug to its molecular target in vivo in these patients
Determine the effects of this drug on angiogenesis in these patients
Determine antitumor activity of this drug by measuring tumor size and glucose uptake in these patients
Determine the pharmacokinetics of this drug in these patients
Determine a recommended phase II dose of this drug based on either the MTD or the optimal biologic response in these patients
OUTLINE This is a dose-escalation study
Patients receive monoclonal antibody anti-alpha V beta 3 integrin Medi 522 IV over 30 minutes weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of Medi 522 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 6-30 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 |
|---|---|---|---|
| P30CA014520 | NIH | None | None |
| WCCC-CO-01905 | None | None | None |
| NCI-5497 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA014520 |