A Phase I Study Of Medi 522 In Patients With Advanced Tumors
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.
Interventional
Primary Purpose: Treatment
Douglas McNeel, MD, PhD
Study Chair
University of Wisconsin, Madison
United States: Federal Government
CDR0000257810
NCT00049712
October 2002
Name | Location |
|---|---|
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
