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Interleukin-2 in Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT01702896
Recruitment Status : Terminated (PI Decision)
First Posted : October 10, 2012
Results First Posted : February 7, 2018
Last Update Posted : April 5, 2018
Sponsor:
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
Enrollment 8

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Interleukin-2
Hide Arm/Group Description All patients received Interleukin-2
Period Title: Overall Study
Started 8
Completed 0
Not Completed 8
Arm/Group Title Number of Participants
Hide Arm/Group Description Treated with Interleukin-2
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
4
  50.0%
Male
4
  50.0%
1.Primary Outcome
Title Response Rate
Hide Description Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).
Time Frame Measured until Disease Progression or death from any cause up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Response Rate
Hide Arm/Group Description:
Percentage of patient who received IL-2 that had a positive response to treatment.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Median Duration of Response
Hide Description Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.
Time Frame Measured until Disease Progression or death from any cause up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Interleukin-2
Hide Arm/Group Description:

Interleukin-2

Interleukin-2: Interleukin-2

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Median Survival
Hide Description Measured from date of entry on study until date of death
Time Frame From time of study entry until death, up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected
Arm/Group Title Median Survival
Hide Arm/Group Description:
Median survival was measured from date of entry on study until date of death
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adverse Events
Hide Arm/Group Description Patients receiving Interleukin-2
All-Cause Mortality
Adverse Events
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adverse Events
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adverse Events
Affected / at Risk (%)
Total   0/8 (0.00%) 
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
ClinicalTrials.gov 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