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Tracking Information | |||||
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First Received Date ICMJE | April 7, 2003 | ||||
Last Updated Date | July 22, 2009 | ||||
Start Date ICMJE | February 2003 | ||||
Current Primary Outcome Measures ICMJE |
Antitumor effect by Kaposi's sarcoma (KS) response criteria in patients with HIV-associated KS [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Antitumor effect by Kaposi's sarcoma (KS) response criteria in patients with HIV-associated KS | ||||
Change History | Complete list of historical versions of study NCT00058136 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Descriptive Information | |||||
Brief Title ICMJE | Bevacizumab in Treating Patients With Kaposi's Sarcoma | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | Phase II | ||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Treatment, Open Label | ||||
Condition ICMJE | Sarcoma | ||||
Intervention ICMJE | Biological: bevacizumab | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Suspended | ||||
Estimated Enrollment ICMJE | 27 | ||||
Completion Date | |||||
Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00058136 | ||||
Responsible Party | Robert Yarchoan, NCI - Center for Cancer Research | ||||
Study ID Numbers ICMJE | CDR0000287014, NCI-03-C-0110, NCI-5513 | ||||
Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | July 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |