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Interleukin-2 in Metastatic Kidney Cancer

This study has been terminated.
(PI Decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01702909
First Posted: October 10, 2012
Last Update Posted: September 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Western Regional Medical Center
Results First Submitted: August 14, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Renal Cell Cancer Metastatic
Kidney Cancer Metastatic
Intervention: Drug: Interleukin-2

  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
Interleukin-2 Interleukin 2 (IL-2) is naturally produced by the body to help fight infection and prevent autoimmune diseases. In cancer treatment, IL-2 is designed to target adaptive immune cells, such as T-cells and B-cells, to respond to tumors. IL-2 may help the body produce antigen-fighting T-cells and stimulate B-cells to produce more antibodies.

Participant Flow:   Overall Study
    Interleukin-2
STARTED   7 
COMPLETED   7 
NOT COMPLETED   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
Number of Participants Treated with Interleukin-2

Baseline Measures
   Number of Participants 
Overall Participants Analyzed 
[Units: Participants]
 7 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      6  85.7% 
>=65 years      1  14.3% 
Age 
[Units: Years]
Median (Full Range)
 58 
 (54 to 67) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  42.9% 
Male      4  57.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   7 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Response Using RECIST Criteria   [ Time Frame: Measured until Disease Progression or death from any cause up to 2 year ]

2.  Secondary:   Median Survival   [ Time Frame: measured from date of first dose until date of death ]

3.  Secondary:   Median Duration of Response   [ Time Frame: Measured from first response until Disease Progression or death from any cause up to 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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: Steffany Gayton
Organization: Western Regional Medical Center
phone: 623-207-3778
e-mail: Steffany.Gayton@ctca-hope.com



Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01702909     History of Changes
Other Study ID Numbers: 12-08
First Submitted: October 4, 2012
First Posted: October 10, 2012
Results First Submitted: August 14, 2017
Results First Posted: September 27, 2017
Last Update Posted: September 27, 2017