Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery
Condition: Adult Angiosarcoma; Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma
MeSH terms: Sarcoma; Hemangiosarcoma
Intervention: Laboratory Biomarker Analysis; Trebananib
Intervention description: Correlative studies; Given IV
Intervention MeSH terms: Trebananib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well trebananib works in treating patients with advanced
      angiosarcoma that cannot be removed by surgery. Trebananib may stop the growth of tumor cells
      by blocking blood flow to the tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed angiosarcoma that is unresectable

          -  Patients must have measurable disease per Response Evaluation Criteria in Solid
             Tumors(RECIST) 1.1, defined as at least one lesion that can be accurately measured in
             at least one dimension (longest diameter to be recorded for non-nodal lesions and
             short axis for nodal lesions) as >= 2 cm with conventional techniques or as >= 1 cm
             with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or
             calipers by clinical exam

          -  Patients must have had =< 4 prior systemic treatment regimens

          -  Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky >= 70%

          -  Life expectancy of greater than 3 months

          -  Leukocytes >= 3,000/mcL

          -  Absolute neutrophil count >= 1,500/mcL

          -  Hemoglobin >= 8.5g/dL

          -  Platelet count >= 60,000/mcL

          -  Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) =<
             2.5 times institutional ULN

          -  Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase[SGPT]) =< 2.5
             times institutional ULN

          -  Partial thromboplastin time (PTT) or activated (a)PTT =< 1.5 times ULN per
             institutional laboratory range

          -  International normalized ratio(INR) =< 1.5 (unless on warfarin)

          -  Creatinine =< 1.5 times ULN OR creatinine clearance > 40 mL/min per 24-hour urine
             collection or calculated according to the Cockcroft-Gault formula

          -  Urinary protein =< 30 mg/dL in urinalysis or =< 1+ on dipstick, unless quantitative
             protein is < 1,000 mg in a 24-hour urine sample

          -  Women of childbearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation

               -  Women of child-bearing potential and men must agree to use adequate contraception
                  (hormonal or 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 she or her partner is participating in this study,
                  she should inform her treating physician immediately

               -  Breastfeeding must be discontinued if the mother is treated with AMG 386; these
                  potential risks may also apply to other agents used in this study

               -  Female of childbearing potential is defined as the following: A female of
                  childbearing potential is a sexually mature woman who: 1) has not undergone a
                  hysterectomy or bilateral oophorectomy or 2) has not been naturally
                  postmenopausal (amenorrhea following cancer therapy does not rule out
                  childbearing potential) for at least 24 consecutive months (i.e., has had menses
                  at any time in the preceding 24 consecutive months)

          -  Generally well-controlled blood pressure with systolic blood pressure =< 150 mm Hg and
             diastolic blood pressure =< 90 mm Hg (Note: The use of anti-hypertensive medications
             to control hypertension is permitted)

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  No known history of brain metastases

          -  History of clinically significant bleeding within 6 months of enrollment/randomization

          -  No unresolved toxicities from prior systemic therapy that are Common Terminology
             Criteria for Adverse Events (CTCAE) version 4.0 >= grade 2 in severity except alopecia

          -  Currently or previously treated with AMG 386, or other molecules that inhibit the
             angiopoietins or Tie2 receptor

          -  Clinically significant cardiovascular disease within 12 months prior to
             enrollment/randomization, including myocardial infarction, unstable angina, grade 2 or
             greater (CTCAE version 4.0) peripheral vascular disease, cerebrovascular accident,
             transient ischemic attack, congestive heart failure, or arrhythmias not controlled by
             outpatient medication or placement of percutaneous transluminal coronary
             angioplasty/stent

          -  Major surgery within 28 days prior to enrollment or still recovering from prior
             surgery

          -  Treatment within 30 days prior to enrollment with strong immune modulators including,
             but not limited to, systemic cyclosporine, tacrolimus, sirolimus, mycophenolate
             mofetil, methotrexate, azathioprine, rapamycin, thalidomide, lenalidomide, and
             targeted immune modulators such as abatacept (CTLA-4- -Ig),adalimumab, alefacept,
             anakinra, belatacept (LEA29Y), efalizumab, etanercept, infliximab, or rituximab

          -  Non-healing wound

          -  Subject not consenting to the use of highly effective contraceptive precautions (e.g.,
             double barrier method [i.e., condom plus diaphragm]) during the course of the study
             and for 6 months after administration of the last study medication

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to AMG 386

          -  History of allergic reactions to bacterially-produced proteins

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from adverse events due to agents administered more than 4 weeks earlier

          -  Patients who have not yet completed at least 21 days (30 days for prior monoclonal
             antibody therapy) since ending other investigational device or drug trials, or who are
             currently receiving other investigational treatments

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Non-pregnant, non-nursing; Note: Women of child bearing potential must have a
             pregnancy test, serum based within 7 days prior to registration; this is because AMG
             386 is an inhibitor of angiogenesis with the potential for teratogenic or
             abortifacient effects

          -  Patients with a history of venous or arterial thromboembolism within 12 months prior
             to enrollment/randomization should be excluded