Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00055237
First received: February 21, 2003
Last updated: July 30, 2012
Last verified: July 2012
Results First Received: June 19, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Kaposi's Sarcoma
HIV Infections
HIV Seronegativity
Intervention: Biological: Bevacizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected) 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks

Participant Flow:   Overall Study
    Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma     Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)  
STARTED     17     2  
COMPLETED     17     2  
NOT COMPLETED     0     0  



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   Response Rate   [ Time Frame: 36 months ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 70 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information