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

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ClinicalTrials.gov Identifier: NCT00055237
Recruitment Status : Completed
First Posted : February 21, 2003
Results First Posted : July 26, 2012
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):

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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

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

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

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

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


  Serious Adverse Events

Time Frame 70 months
Additional Description No text entered.

Reporting Groups
  Description
Cohort 1 & 2: Pts With HIV-associated and Classic KS 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks

Serious Adverse Events
    Cohort 1 & 2: Pts With HIV-associated and Classic KS
Total, All-Cause Mortality   
# participants affected / at risk   0/19 (0.00%) 
Total, Serious Adverse Events   
# participants affected / at risk   4/19 (21.05%) 
Blood and lymphatic system disorders   
Transfusion: Platelets † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Gastrointestinal disorders   
Vomit † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
General disorders   
Syndromes-Other (Specify, toxic shock syndrome) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Infections and infestations   
Infection † 1 [3]   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Infection/Febrile Neutropenia-Other (Specify, from leg cellulitis) † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   3 
Investigations   
Bicarbonate † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
CPK (creatine phosphokinase) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Creatinine † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Hemoglobin † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   3 
Partial thromboplastin time (PTT) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Platelets † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Metabolism and nutrition disorders   
Acidosis (metabolic or respiratory) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Renal and urinary disorders   
Renal failure † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome (ARDS) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Hypoxia † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Vascular disorders   
Hypotension † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Events were collected by systematic assessment
1 Term from vocabulary, CTCv2.0
[3] (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e




  Other Adverse Events


  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
No text entered.


  More Information