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| Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00288015 |
Purpose
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with angiosarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Biological: bevacizumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | An Open Label Multicenter Phase II Study of Bevacizumab for the Treatment of Angiosarcoma |
| Estimated Enrollment: | 31 |
| Study Start Date: | October 2005 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 to 4 months for 2 years.
PROJECTED ACCRUAL: A total of 31 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed angiosarcoma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| Rebecca and John Moores UCSD Cancer Center | Recruiting |
| La Jolla, California, United States, 92093-0658 | |
| Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer 858-822-5354 cancercto@ucsd.edu | |
| United States, Illinois | |
| Evanston Hospital | Recruiting |
| Evanston, Illinois, United States, 60201-1781 | |
| Contact: Clinical Trials Office - Evanston Hospital 847-570-1381 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611-3013 | |
| Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center CCOP Research Base | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Clinical Trials Office - Fox Chase Cancer Center CCOP Research 215-728-2983 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| Study Chair: | Mark Agulnik, MD | Robert H. Lurie Cancer Center |
| Investigator: | Bruce E. Brockstein, MD | Evanston NorthShore University HealthSystem |
More Information
| Responsible Party: | Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Mark Agulnik ) |
| Study ID Numbers: | CDR0000456253, NU-04S1 |
| Study First Received: | February 6, 2006 |
| Last Updated: | June 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00288015 History of Changes |
| Health Authority: | Unspecified |
|
adult angiosarcoma recurrent adult soft tissue sarcoma stage I adult soft tissue sarcoma |
stage II adult soft tissue sarcoma stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma |
|
Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Sarcoma |
Bevacizumab Hemangiosarcoma Angiogenesis Inhibitors Recurrence |
|
Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Physiological Effects of Drugs Hemangiosarcoma Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms, Connective and Soft Tissue Neoplasms Therapeutic Uses Sarcoma Neoplasms, Vascular Tissue Angiogenesis Modulating Agents Growth Inhibitors |