Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery
Condition: 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
MeSH terms: Sarcoma; Osteosarcoma; Chondrosarcoma; Bone Neoplasms; Sarcoma, Clear Cell; Recurrence
Intervention: therapeutic angiotensin-(1-7); laboratory biomarker analysis
Intervention description: Given SC; Correlative study
Intervention MeSH terms: Angiotensin I (1-7)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a histologically or cytologically confirmed sarcoma that is
             metastatic or unresectable and have progressed despite 1 or 2 prior treatment regimens
             with chemotherapy or targeted anti-cancer agents such as imatinib

          -  Prior treatment: >= 4 weeks since completion of radiation or chemotherapy, except for
             >= 6 weeks for Melphalan, nitrosoureas, or mitomycin-C

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2

          -  Absolute neutrophil count >= 1,500/Microliter (mcL)

          -  Platelets >= 100,000/mcL

          -  Total bilirubin =< 2 mg/dL

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) <
             3 X upper limit or normal (ULN)

          -  Estimated (est.) creatinine clearance > 30 mL/min

          -  Measurable disease, defined as at least one lesion that can be accurately measured in
             at least one dimension as > 10 mm

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or double-barrier method of birth control; abstinence) prior to study entry
             and for the duration of study participation; should a woman become pregnant or suspect
             she is pregnant while participating in this study, she should inform her treating
             physician immediately

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients may not be receiving any other investigational agents for cancer treatment

          -  Patients with evidence of bleeding diathesis are ineligible

          -  No concurrent treatment with angiotensin-converting-enzyme (ACE) inhibitors or
             angiotensin II receptor blockers (ARBs)

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, uncontrolled hypertension or hypotension, or psychiatric illness/social
             situations that would limit compliance with study requirements

          -  Pregnant and nursing women are excluded from this study