Bevacizumab and Aldesleukin in Treating Patients With Metastatic Clear Cell Carcinoma of the Kidney

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jorge Garcia, MD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00853021
First received: February 26, 2009
Last updated: July 28, 2015
Last verified: July 2015
Results First Received: July 28, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Cancer
Interventions: Biological: aldesleukin
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
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Reporting Groups
  Description
Bevacizumab and Aldesleukin

aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.

bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.


Participant Flow:   Overall Study
    Bevacizumab and Aldesleukin  
STARTED     26  
COMPLETED     21  
NOT COMPLETED     5  
Adverse Event                 2  
Withdrawal by Subject                 2  
Death                 1  



  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
Bevacizumab and Aldesleukin

aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.

bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.


Baseline Measures
    Bevacizumab and Aldesleukin  
Number of Participants  
[units: participants]
  26  
Age  
[units: years]
Mean (Standard Deviation)
  59.4  (6.7)  
Gender  
[units: participants]
 
Female     4  
Male     22  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     25  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     25  
More than one race     0  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
 
United States     26  



  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: From baseline (day -14) to disease progression (reported at 2 years) ]

2.  Secondary:   Objective Response Rate (Complete and Partial Response)   [ Time Frame: 4 weeks after treatment ]

3.  Secondary:   Percentage of Patients With Constitutional Adverse Events   [ Time Frame: From start of treatment to 30 days after treatment ]

4.  Secondary:   Percentage of Patients With Neutropenia   [ Time Frame: From start of treatment to 30 days after treatment ]

5.  Other Pre-specified:   Peripheral Blood CD1c+ Myeloid Dendritic Cells   [ Time Frame: Baseline (day -14), Beginning and end of cycle 1 (day 1, 57) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Other Pre-specified:   CD303+ Plasmacytoid Dendritic Cells   [ Time Frame: Baseline (day -14), beginning and end of cycle 1 (day 1, 57) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Other Pre-specified:   IL-8 Levels   [ Time Frame: Baseline (day -14), beginning and end of cycle 1 (day 1, 57) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Other Pre-specified:   CD4+ Treg Cells   [ Time Frame: Baseline (day -14), beginning and end of cycle 1 (day 1, 57) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Other Pre-specified:   CD25+ Treg Cells   [ Time Frame: Baseline (day -14), beginning and end of cycle 1 (day 1, 57) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Other Pre-specified:   T-helper Cells (Type 1,2)   [ Time Frame: Baseline (day -14), beginning and end of cycle 1 (day 1, 57) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jorge Garcia
Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
phone: 216-444-7774
e-mail: garciaj4@ccf.org



Responsible Party: Jorge Garcia, MD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00853021     History of Changes
Other Study ID Numbers: CASE8804
P30CA043703 ( US NIH Grant/Contract Award Number )
CASE8804 ( Other Identifier: Case Comprehensive Cancer Center )
7493 ( Other Identifier: Cleveland Clinic IRB )
Study First Received: February 26, 2009
Results First Received: July 28, 2015
Last Updated: July 28, 2015
Health Authority: United States: Food and Drug Administration