View Clinical Trial (Medical Research Study)
A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02114 |
| Conditions: |
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Soft Tissue Sarcoma - Fibrous Histiocytoma - Liposarcoma - Leiomyosarcoma - Fibrosarcoma - Synovial Sarcoma |
| Purpose: |
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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.
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| Study Summary: |
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- 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.
- Radiation therapy will begin 2 weeks after the first bevacizumab infusion and will be
delivered 5 days per week over a period of 6 weeks. This is done as an outpatient
procedure. Each 2 week period will be considered a separate treatment cycle.
Participants will be treated with radiation therapy for a maximum of 3 cycles (6
weeks).
- A surgeon will evaluate the participants tumor by radiologic studies before study
treatment to determine if surgical removal is possible. After the completion of study
treatment, a surgeon will repeat the evaluation of the tumor. Surgery will performed
6-7 weeks after the completion of radiation therapy.
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| Criteria: |
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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 CNS disease
- Serious, non-healing wound, ulcer, or bone fracture
- Clinically significant cardiovascular disease, 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
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| NCT ID: |
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NCT00356031 |
| Primary Contact: |
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Principal Investigator
Yen-Lin Chen, MD
Massachusetts General Hospital
Yen-Lin Chen, MD
Phone: 617-726-6876
Email: ychen9@partners.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02114
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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