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
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
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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  
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 ]

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


  Serious Adverse Events
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Time Frame No text entered.
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, 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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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.  


Results Point of Contact:  
Name/Title: Robert Yarchoan, M.D.
Organization: National Cancer Institute, National Institutes of Health
phone: 301-496-0328
e-mail: Robert.Yarchoan@nih.gov


Publications of Results:

Responsible Party: Robert Yarchoan, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00055237     History of Changes
Obsolete Identifiers: NCT00058136
Other Study ID Numbers: 030110, 03-C-0110
Study First Received: February 21, 2003
Results First Received: June 19, 2012
Last Updated: July 30, 2012
Health Authority: United States: Federal Government