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:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00356031
First received: July 21, 2006
Last updated: April 27, 2010
Last verified: April 2010
  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:


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:
    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/
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
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
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:
Histiocytoma
Fibrosarcoma
Leiomyosarcoma
Liposarcoma
Sarcoma, Synovial
Histiocytoma, Benign Fibrous
Sarcoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Muscle Tissue
Neoplasms, Adipose Tissue
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014