Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery
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 OOPD
Clear Cell Sarcoma of the Kidney
Recurrent Adult Soft Tissue Sarcoma
Recurrent Uterine Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage III Uterine Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Stage IV Uterine Sarcoma
Drug: therapeutic angiotensin-(1-7)
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical Trial of Angiotensin 1-7 For the Second or Third Line Treatment of Patients With Metastatic or Unresectable Sarcomas|
- Antitumor activity as assessed by objective tumor response [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]'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. 95% Confidence Intervals will be estimated. Fisher's exact and t-tests or Wilcoxon rank-sum tests used to assess the univariate associations of patient characteristics with response. Logistic regression used to determine which covariates are jointly predictive of response.
- Toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]95% Confidence Intervals will be estimated. The frequency and severity of all side effects and toxicities will be tabulated and analyzed using categorical techniques.
- Time to disease progression [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
- Plasma levels of angiogenic peptides including placental growth factor (PlGF) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- Plasma levels of angiogenic peptides including PIGF [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (antiangiogenesis therapy)
Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
Drug: therapeutic angiotensin-(1-7)
Other Names:Other: laboratory biomarker analysis
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.
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).
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.
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||William Petty||Wake Forest School of Medicine|