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

Sponsor:

Collaborator:

National Institutes of Health (NIH)

Information provided by:

Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00356031

First received: July 21, 2006

Last updated: April 27, 2010

Last verified: April 2010

History of Changes

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: Malignant Mesenchymal Tumor Soft Tissue Sarcoma Synovial Sarcoma Liposarcoma Leiomyosarcoma Fibrosarcoma Dermatofibroma

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:

Given intravenously every 2 weeks for a total of 2 doses

Given two weeks after the first bevacizumab infusion and delivered 5 days a week over 6 weeks/

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.
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 (Adult, Senior)
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

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

National Institutes of Health (NIH)

Investigators


Principal Investigator:	Yen-Lin Chen, MD	Massachusetts General Hospital

More Information


Responsible Party:	Yen-Lin Chen, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00356031 History of Changes
Other Study ID Numbers:	05-090 1R21CA117128-01A1
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 Sarcoma, Synovial Leiomyosarcoma Liposarcoma Histiocytoma Fibrosarcoma Histiocytoma, Benign Fibrous Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Muscle Tissue	Neoplasms, Adipose Tissue Neoplasms, Connective Tissue Neoplasms, Fibrous Tissue Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents

ClinicalTrials.gov processed this record on September 23, 2016

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