NCT01553539

Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery

A Phase II Clinical Trial of Angiotensin 1-7 For the Second or Third Line Treatment of Patients With Metastatic or Unresectable Sarcomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Bone Cancer
• Chondrosarcoma
• Clear Cell Sarcoma of the Kidney
• Metastatic Osteosarcoma
• Ovarian Sarcoma
• Recurrent Adult Soft Tissue Sarcoma
• Recurrent Osteosarcoma
• Recurrent Uterine Sarcoma
• Stage III Adult Soft Tissue Sarcoma
• Stage III Uterine Sarcoma
• Stage IV Adult Soft Tissue Sarcoma
• Stage IV Uterine Sarcoma

Interventions

Type	Name	Description
DRUG	therapeutic angiotensin-(1-7)	Given SC
OTHER	laboratory biomarker analysis	Correlative study

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-03-14
• Last updated: 2018-07-05
• Results posted: 2014-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study