Bevacizumab and Radiation Therapy for Sarcomas
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Massachusetts General Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Massachusetts General Hospital
Collaborator:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00356031
First received: July 21, 2006
Last updated: April 27, 2010
Last verified: April 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Soft Tissue Sarcoma Fibrous Histiocytoma Liposarcoma Leiomyosarcoma Fibrosarcoma Synovial Sarcoma |
Drug: Bevacizumab Procedure: Radiation Therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas |
Resource links provided by NLM:
MedlinePlus related topics:
Soft Tissue Sarcoma
Drug Information available for:
Bevacizumab
Genetic and Rare Diseases Information Center resources:
Dermatofibroma
Fibrosarcoma
Leiomyosarcoma
Liposarcoma
Malignant Mesenchymal Tumor
Soft Tissue Sarcoma
Synovial Sarcoma
U.S. FDA Resources
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- To determine the objective response rate for neoadjuvant bevacizumab combined with radiation therapy for intermediate and high-risk soft tissue sarcomas. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To analyze the biologic effects of this regimen on tumor vasculature, blood flow, and oxygenation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- to obtain preliminary data regarding local control, distant control, disease-free survival, and overall survival with this regimen. [ Time Frame: TBD ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 28 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Bevacizumab
Given intravenously every 2 weeks for a total of 2 doses
Procedure: Radiation Therapy
Given two weeks after the first bevacizumab infusion and delivered 5 days a week over 6 weeks/
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356031
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356031
Contacts
| Contact: Yen-Lin Chen, MD | 617-726-6876 | ychen9@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Yen-Lin Chen, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Yen-Lin Chen, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00356031 History of Changes |
| Other Study ID Numbers: | 05-090, 1 R21 CA117128-01A1 |
| Study First Received: | July 21, 2006 |
| Last Updated: | April 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
Avastin |
Additional relevant MeSH terms:
|
Sarcoma Histiocytoma, Benign Fibrous Histiocytoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Bevacizumab |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents Growth Inhibitors Growth Substances Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015