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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Yarchoan, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00055237
First received: February 21, 2003
Last updated: August 7, 2017
Last verified: August 2017
Results First Received: 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


  Baseline Characteristics
  Hide Baseline Characteristics

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 
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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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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