Interleukin-2 in Metastatic Kidney Cancer

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. Identifier: NCT01702909
Recruitment Status : Terminated (PI Decision)
First Posted : October 10, 2012
Results First Posted : September 27, 2017
Last Update Posted : February 8, 2018
Information provided by (Responsible Party):
Western Regional Medical Center

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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
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

  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.
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Reporting Groups
Number of Participants Treated with Interleukin-2

Baseline Measures
   Number of Participants 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      6  85.7% 
>=65 years      1  14.3% 
[Units: Years]
Median (Full Range)
 (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

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 Duration of Response   [ Time Frame: Measured from first response until Disease Progression or death from any cause up to 2 years ]

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

  Serious Adverse Events

  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
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  More Information

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

Results Point of Contact:  
Name/Title: Jessica L. Coats
Organization: Western Regional Medical Center
phone: 623-207-3899

Responsible Party: Western Regional Medical Center 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: February 8, 2018