Endostatin in Treating Patients With Advanced Refractory Solid Tumors
RATIONALE: Endostatin may stop the growth of solid tumors by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of endostatin in treating patients who have advanced refractory solid tumors.
|Unspecified Adult Solid Tumor, Protocol Specific||Biological: recombinant human endostatin||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of Endostatin in Advanced Cancer Patients|
|Study Start Date:||March 2000|
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and Phase II dose of endostatin in patients with advanced refractory solid tumors. II. Determine the qualitative and quantitative nature of the toxicities encountered with endostatin in this patient population. III. Evaluate the basic pharmacokinetics and metabolism of endostatin by measurement of plasma levels by EIA and mass spectrometry in this patient population. IV. Investigate the relationship between pharmacokinetic parameters and toxicity in this patient population. V. Evaluate biologic evidence of angiogenesis inhibition in patients receiving endostatin.
OUTLINE: This is a dose escalation study. Patients receive endostatin IV over 1 hour daily for 28 days, followed by 1 week of rest. Patients receive subsequent courses of daily therapy in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients receive escalating doses of endostatin 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 toxicities.
PROJECTED ACCRUAL: Approximately 30-40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004872
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||James P. Thomas, MD, PhD||Ohio State University Comprehensive Cancer Center|