RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have advanced or metastatic soft tissue sarcoma.
OBJECTIVES: * Determine the objective tumor response rate in patients with advanced or metastatic soft tissue sarcoma with prior exposure to anthracycline-based chemotherapy when treated with soblidotin. * Determine the duration of response in patients treated with this drug. * Determine the time to tumor progression in patients treated with this drug. * Determine the median survival time and 12-month survival rate of patients treated with this drug. * Determine the quantitative and qualitative toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive soblidotin IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 12 months.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
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University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Veterans Affairs Medical Center - San Juan
San Juan, Puerto Rico