Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00126490
First received: August 2, 2005
Last updated: December 6, 2013
Last verified: December 2013
Results First Received: May 29, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions: Biological: bevacizumab
Biological: aldesleukin
Other: laboratory biomarker analysis

  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
The recruitment period began 03/23/2005 and accrual was closed 8/21/2007 due to slow accrual.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
24 enrolled but 5 were never treated (moved away, creatinine too high, Hospice before starting, lived too far away to come, chromophobe subtype after review of pathology)

Reporting Groups
  Description
Treatment (Bevacizumab, Aldesleukin) Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Bevacizumab, Aldesleukin)  
STARTED     19  
COMPLETED     18  
NOT COMPLETED     1  
Stopped after 1 infusion (fall/injury)                 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.
18 of the 19 who started treatment were evaluable. One participant had to withdraw after only one infusion because they fell and broke both wrists.

Reporting Groups
  Description
Treatment (Bevacizumab, Aldesleukin) Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Treatment (Bevacizumab, Aldesleukin)  
Number of Participants  
[units: participants]
  18  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     9  
Age  
[units: years]
Median ( Full Range )
  66  
  ( 41 to 84 )  
Gender  
[units: participants]
 
Female     3  
Male     15  
Region of Enrollment  
[units: participants]
 
United States     18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Evaluable Participants With Complete Response (CR) and Partial Response (PR) at One Year   [ Time Frame: 1 year ]

2.  Secondary:   Number of Evaluable Participants With Overall Survival (OS) at 2 Years   [ Time Frame: 2 years from start of treatment ]

3.  Secondary:   Number of Evaluable Participants With Progression Free Survival (PFS)   [ Time Frame: Up to 2 years ]

4.  Secondary:   Pearson Correlation Coefficients of Dendritic Cell (DC):Immature Cell (ImC) Ratio With DC Function   [ Time Frame: At baseline, at days 4-5, 9-10 (of course 1), and at the end of treatment ]

5.  Secondary:   Number of Participants With Possibly Related Serious Adverse Events (SAEs)   [ Time Frame: Up to 30 days after completion of treatment ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
Investigators planned to have 38 participants treated on this study. "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.  


Results Point of Contact:  
Name/Title: Mayer Fishman, M.D., Ph.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-8311
e-mail: mayer.fishman@moffitt.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00126490     History of Changes
Other Study ID Numbers: NCI-2012-02663, NCI-2012-02663, CDR0000434852, MCC-IRB-102782, NCI-6438, MCC 13921, 6438
Study First Received: August 2, 2005
Results First Received: May 29, 2013
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration