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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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
Total Total of all reporting groups

Baseline Measures
    Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma     Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)     Total  
Number of Participants  
[units: participants]
  17     2     19  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     2     17  
>=65 years     2     0     2  
Age  
[units: years]
Mean ± Standard Deviation
  42  ± 9.3     58  ± 12.7     50  ± 11  
Gender  
[units: participants]
     
Female     1     0     1  
Male     16     2     18  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     3     0     3  
Not Hispanic or Latino     14     2     16  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     17     2     19  



  Outcome Measures
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1.  Primary:   Response Rate   [ Time Frame: 36 months ]
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Measure Type Primary
Measure Title Response Rate
Measure Description Percentage of participants with a complete response (CR) + partial response (PR)per the Modified AIDS Clinical Trial Group Criteria (ACTG) for HIV-KS. PR is a 50% decrease in the number and/or size of previously existing lesions for 4 weeks; or complete flattening of at least 50% of all previously raised lesions lasting for at least 4 weeks; or a 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions lasting for at least 4 weeks; CR is the absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks.
Time Frame 36 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Cohort 2 is not reported here because response rate in HIV negative patients was a secondary outcome.

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

Measured Values
    Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma  
Number of Participants Analyzed  
[units: participants]
  16  
Response Rate  
[units: Percentage¬†of¬†participants]
Mean ( 95% Confidence Interval )
  31  
  ( 11 to 58.7 )  


Statistical Analysis 1 for Response Rate
Groups [1] Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma
Method [2] sample estimate with 95% CI
proportion estimate,binomial exact 95%CI [3] 31
Standard Deviation ± 11.6
95% Confidence Interval ( 11 to 58.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant method information, such as adjustments or degrees of freedom:
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[3] Other relevant estimation information:
  As stated in the Outcome statistical Analysis 1. Section, the confidence interval was calculated using binomial exact statistics. The standard deviation is based on that calculation.



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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