Bevacizumab and Radiation Therapy for Sarcomas
Condition: Soft Tissue Sarcoma; Fibrous Histiocytoma; Liposarcoma; Leiomyosarcoma; Fibrosarcoma; Synovial Sarcoma
MeSH terms: Sarcoma; Leiomyosarcoma; Liposarcoma; Sarcoma, Synovial; Fibrosarcoma; Histiocytoma; Histiocytoma, Benign Fibrous
Intervention: Bevacizumab; Radiation Therapy; Surgery
Intervention description: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses; External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.; Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy.
Intervention MeSH terms: Bevacizumab
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
Keywords: Avastin

Summary:

      The main purpose of this study is to test the effectiveness of bevacizumab in combination
      with radiation therapy to see what effects (good or bad) they have on patients with soft
      tissue sarcoma. Bevacizumab is an antibody designed specifically to slow or stop the growth
      of cancerous tumors by decreasing the blood supply to the tumor. Bevacizumab is approved by
      the FDA in combination with intravenous 5-fluorouracil-based chemotherapy as a treatment for
      patients with cancer of the colon or rectum that has spread. However, the use of bevacizumab
      in combination with radiation for sarcomas is still under investigation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary soft tissue sarcoma (STS) or an isolated local recurrence of STS. Open
             incisional biopsy or core biopsies should be performed within 8 weeks prior to
             registration

          -  Tumor grade of intermediate or high grade

          -  Tumor must be located on the upper extremity, the lower extremity, trunk,
             retroperitoneum, or pelvis

          -  Primary tumors must be > 5.0cm in maximal diameter and local recurrence can be any
             size

          -  18 years of age or older

          -  Zubrod performance status of 0-2

          -  Adequate organ and marrow function

        Exclusion Criteria:

          -  Metastatic disease

          -  Pregnant or lactating women

          -  HIV positive patients

          -  Prior treatment with radiation, chemotherapy or biotherapy for this tumor

          -  History or evidence of central nervous system (CNS) disease

          -  Serious, non-healing wound, ulcer, or bone fracture

          -  Clinically significant cardiovascular disease, New York Heart Association (NYHA) Grade
             II or greater congestive heart failure, serious cardiac arrhythmia requiring
             medication, or Grade II or greater peripheral vascular disease within 1 year

          -  History of stroke within the past 6 months

          -  Major surgical procedure or significant traumatic injury within 28 days

          -  Current or recent (within 10 days) use of full-dose oral or parenteral anticoagulants
             or thrombolytic agents.

          -  Presence of bleeding diathesis or coagulopathy

          -  Proteinuria at baseline or clinically significant impairment of renal function

          -  History of abdominal fistula, gastrointestinal perforation, or inta-abdominal abscess
             within the past 6 months

          -  Documented history of uncontrolled seizures

          -  Grade 2 or greater sensory neuropathy based upon the NCI CTCAE, version 3.0

          -  Known history of deep vein thrombosis or pulmonary embolus

          -  Known hypercoagulable disorder

          -  History of hepatic cirrhosis or current hepatic dysfunction