NCT00052403

Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors

Phase I Study of Monoclonal Antibody Anti-Anb3 Integrin in Patients With Advanced Solid Tumors

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	monoclonal antibody anti-anb3 integrin
PROCEDURE	anti-cytokine therapy
PROCEDURE	antiangiogenesis therapy
PROCEDURE	antibody therapy
PROCEDURE	biological response modifier therapy
PROCEDURE	growth factor antagonist therapy
PROCEDURE	monoclonal antibody therapy

Timeline

• Start date: 2002-02-01
• First posted: 2003-01-27
• Last updated: 2014-01-16