Monoclonal Antibody Therapy in Treating Patients With Refractory Advanced Solid Tumors or Lymphoma

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Lymphoma; Small Intestine Cancer

• Registration Number: NCT00049712
• Lead Sponsor: University of Wisconsin, Madison

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.

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.

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2002-11-12
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2015-07
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Wisconsin Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States