A Phase II Clinical Trial of Angiotensin 1-7 For the Second or Third Line Treatment of Patients With Metastatic or Unresectable Sarcomas
- To evaluate the response rate in patients with chemotherapy-refractory, metastatic or
unresectable sarcoma treated with therapeutic angiotensin-(1-7).
- To evaluate toxicities associated with this treatment in these patients.
- To assess time to progression and overall survival of patients treated with therapeutic
- To evaluate accumulation of therapeutic angiotensin-(1-7) after 21 days of continuous
treatment and quantify changes in plasma levels of angiogenic peptides including
OUTLINE: Patients receive therapeutic angiotensin-(1-7) subcutaneously once daily. Treatment
continues daily in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for pharmacokinetic and other biomarker analyses.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response according to RECIST criteria
W. Jeffrey Petty, MD
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|