This phase II trial studies how well therapeutic angiotensin-(1-7) works as second-line therapy or third-line therapy in treating patients with metastatic sarcoma that cannot be removed by surgery. Therapeutic angiotensin-(1-7) may stop the growth of sarcoma by blocking blood flow to the tumor. Funding Source - FDA Office of Orphan Drug Products (OOPD)
PRIMARY OBJECTIVES: I. To evaluate the response rate of chemotherapy-refractory sarcomas to 20 mg per day of single-agent Ang(Angiotensin)-(1-7) or 10 mg per day of single-agent Ang-(1-7) if excessive toxicity is observed at the 20 mg dose. II. To evaluate toxicities associated with single-agent Ang-(1-7) when given to patients with chemotherapy-refractory sarcomas. SECONDARY OBJECTIVES: I. To assess time to progression (TTP) and overall survival (OS) in patients treated with Ang-(1-7). II. To evaluate accumulation of Ang-(1-7) after 21 days of continuous treatment and quantify changes in plasma levels of angiogenic peptides including placental growth factor (PlGF). OUTLINE: Patients receive therapeutic angiotensin-(1-7) subcutaneously (SC) once daily in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Given SC
Correlative study
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response
'Activity' will be operationalized using objective tumor response, which will be estimated as the proportion of partial and complete responders (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) among all evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Approximately 1 year
Number of Participants Who Experienced Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
See the adverse event tables for specifics.
Time frame: Approximately 1 year
Time to Disease Progression
Time frame: Approximately 5 years
Overall Survival
Time frame: Approximately 5 years
Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)
Time frame: Baseline and Day 22
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