Phase II Trial of Dolastatin-10 in Patients With Previously Untreated Recurrent/Metastatic Sarcoma
I. Determine the response rate in patients with recurrent or metastatic soft tissue sarcomas
treated with dolastatin 10.
II. Determine the toxicity of this regimen in this patient population.
OUTLINE: This is an open label, multicenter study. Patients are stratified according to
center, prior therapy, histologic subtype, stage of disease at diagnosis, and current status
of disease (recurrent vs metastatic).
Patients receive dolastatin 10 IV over 10 minutes. Treatment repeats every 21 days in the
absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Margaret von Mehren, MD
Fox Chase Cancer Center
United States: Food and Drug Administration
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|University of Colorado Cancer Center||Denver, Colorado 80262|
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|