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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00055237
First Posted: February 21, 2003
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert Yarchoan, National Institutes of Health Clinical Center (CC)
Results First Submitted: June 19, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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.
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 17   2   19 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      15  88.2%      2 100.0%      17  89.5% 
>=65 years      2  11.8%      0   0.0%      2  10.5% 
Age 
[Units: Years]
Mean (Standard Deviation)
 42  (9.3)   58  (12.7)   50  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1   5.9%      0   0.0%      1   5.3% 
Male      16  94.1%      2 100.0%      18  94.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic      3  17.6%      0   0.0%      3  15.8% 
Not Hispanic or Latino      14  82.4%      2 100.0%      16  84.2% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   17   2   19 


  Outcome Measures
  Show All Outcome Measures

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  

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 
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
Statistical Test Type [2] Superiority or Other
Statistical Method [3] sample estimate with 95% CI
proportion estimate,binomial exact 95%CI [4] 31
95% Confidence Interval 11 to 58.7
Standard Deviation (11.6)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
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[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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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  More Information