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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00058136 |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.
PURPOSE: This phase II trial is to see if bevacizumab works in treating patients who have Kaposi's sarcoma.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Drug: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study Of Intravenous Recombinant Humanized Anti-Vascular Endothelial Cell Growth Factor Antibody (Bevacizumab) In Classical (HIV-Negative) And In AIDS-Associated Kaposi's Sarcoma |
Estimated Enrollment: | 27 |
Study Start Date: | February 2003 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive a loading dose of bevacizumab IV over 90 minutes. Beginning 1 week later, patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 to 6 weeks.
PROJECTED ACCRUAL: A total of 8-27 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No substantial CNS disease, including the following:
No other abnormality that would be scored as a grade 3 toxicity except for the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
HIV-positive patients must be willing to comply with a regimen of highly active antiretroviral therapy (HAART) and meet 1 of the following criteria:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
NCI - HIV and AIDS Malignancy Branch | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: Robert Yarchoan, MD 301-496-8959 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | Robert Yarchoan, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000287014, NCI-03-C-0110, NCI-5513 |
Study First Received: | April 7, 2003 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00058136 |
Health Authority: | Unspecified |
classic Kaposi sarcoma AIDS-related Kaposi sarcoma |
Malignant mesenchymal tumor Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Bevacizumab Soft tissue sarcomas Herpesviridae Infections Virus Diseases |
Neoplasms, Connective and Soft Tissue Kaposi sarcoma Antibodies HIV Infections Sarcoma DNA Virus Infections Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses Growth Substances Physiological Effects of Drugs |
Neoplasms, Vascular Tissue Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |