A Phase I Trial of EMD 121974 in Patients With HIV Related Kaposi's Sarcoma
I. Determine the safety and toxicity of EMD 121974 in patients with HIV related Kaposi's
II. Determine the antiangiogenic activity of this drug in these patients. III. Determine the
antitumor activity of this drug in these patients. IV. Determine the effect of this drug on
CD4 and CD8 cell counts and percentages, and on HIV viral load in these patients.
V. Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose escalation study.
Patients receive EMD 121974 IV twice a week for four weeks. Courses repeat every 4 weeks in
the absence of disease progression. Cohorts of 3-6 patients receive escalating doses of EMD
121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
at which no more than 1 of 6 patients experiences dose limiting toxicities.
Patients are followed for at least 1 month.
PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study within 1 year.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Barbara J. Klencke, MD
University of California, San Francisco
United States: Food and Drug Administration
|University of California San Diego Cancer Center||La Jolla, California 92093-0658|
|UCSF Cancer Center and Cancer Research Institute||San Francisco, California 94115-0128|
|Vanderbilt Cancer Center||Nashville, Tennessee 37232-6838|