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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00049712
Study type Interventional
Source University of Wisconsin, Madison
Contact
Status Completed
Phase Phase 1
Start date October 2002
Completion date February 2006

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