Dolastatin 10 in Treating Patients With Recurrent or Metastatic Soft Tissue Sarcoma
- Registration Number
- NCT00003778
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
Phase II trial to study the effectiveness of dolastatin 10 in treating patients who have recurrent or metastatic soft tissue sarcoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
- Detailed Description
OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm I dolastatin 10 Patients receive dolastatin 10 IV over 10 minutes. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States