Status:
COMPLETED
Bevacizumab and Radiation Therapy for Sarcomas
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Soft Tissue Sarcoma
Fibrous Histiocytoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Bevac...
Detailed Description
* The dose of bevacizumab and radiation therapy will be the same for all participants throughout the study. * Bevacizumab will be given as an intravenous infusion every 2 weeks for a total of 4 doses....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00356031
Start Date
July 1 2006
End Date
March 1 2010
Last Update
May 19 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114