Interleukin-2 in Metastatic Melanoma

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: NCT01702896
Recruitment Status : Terminated (PI Decision)
First Posted : October 10, 2012
Results First Posted : February 7, 2018
Last Update Posted : April 5, 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
Condition: Melanoma 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
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
Interleukin-2 All patients received Interleukin-2

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.
No text entered.

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      8 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      4  50.0% 
Male      4  50.0% 

  Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: Measured until Disease Progression or death from any cause up to 2 years ]

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

3.  Secondary:   Median Survival   [ Time Frame: From time of study entry until death, up to 10 years ]

  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
No text entered.

  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: NCT01702896     History of Changes
Other Study ID Numbers: 12-07
First Submitted: October 4, 2012
First Posted: October 10, 2012
Results First Submitted: September 23, 2017
Results First Posted: February 7, 2018
Last Update Posted: April 5, 2018