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Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors

2014-08-27 03:55:34 | BioPortfolio

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.

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.

Study Design

Primary Purpose: Treatment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention

monoclonal antibody anti-anb3 integrin, anti-cytokine therapy, antiangiogenesis therapy, antibody therapy, biological response modifier therapy, growth factor antagonist therapy, monoclonal antibody therapy

Location

Barbara Ann Karmanos Cancer Institute
Detroit
Michigan
United States
48201

Status

Withdrawn

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:34-0400

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