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Brief Title: EMD 121974 in Treating Patients With Advanced Solid Tumors
Official Title: A Phase I Study of EMD 121974 in Patients With Advanced Solid Tumors
Study ID: NCT00022113
Brief Summary: Phase I trial to study the effectiveness of EMD 121974 in treating patients who have advanced solid tumors. EMD 121974 may slow the growth of solid tumors by stopping blood flow to the tumor
Detailed Description: OBJECTIVES: I. Determine the toxic effects and maximum tolerated dose of EMD 121974 in patients with advanced solid tumors. II. Determine the biologic activity of this drug in these patients. III. Determine the pharmacokinetic profile and plasma biological effects of this drug and identify any relationship with its biologic activity or observed toxicity in these patients. IV. Determine, preliminarily, the antitumor efficacy of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-10 patients receive escalating doses of EMD 121974 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Colorado, Denver, Colorado, United States
Name: Michele Basche
Affiliation: University of Colorado, Denver
Role: PRINCIPAL_INVESTIGATOR