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A Phase II Study of High Dose Bolus IL2 in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy: Efficacy and Biomarker Study

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ClinicalTrials.gov Identifier: NCT02796352
Recruitment Status : Terminated (Slow accrual.)
First Posted : June 10, 2016
Results First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Prometheus Laboratories
Information provided by (Responsible Party):
Ahmad Tarhini, University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Intervention Drug: High dose bolus interleukin-2 (HD IL2)
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Dose Bolus Interleukin-2 (HD IL2)
Hide Arm/Group Description

High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).

The planned treatment consists of 3 courses (6 cycles) of HD IL-2.

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title High Dose Bolus Interleukin-2 (HD IL2)
Hide Arm/Group Description

High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).

The planned treatment consists of 3 courses (6 cycles) of HD IL-2.

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants
63
(63 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Response Rate
Hide Description Percentage of complete responses (CR) plus partial responses (PR), based upon Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
Time Frame Up to 15 months for accrual, plus 6 months of intervention for last subject enrolled (21 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Bolus Interleukin-2 (HD IL2)
Hide Arm/Group Description:

High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).

The planned treatment consists of 3 courses (6 cycles) of HD IL-2.

Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Number of months of survival without disease progression from start of protocol therapy until objective tumor progression or death, per RECIST v1.1
Time Frame Up to 15 months for accrual, plus 6 months of intervention for last subject enrolled, plus 5 years of follow-up (6 years, 9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Bolus Interleukin-2 (HD IL2)
Hide Arm/Group Description:

High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).

The planned treatment consists of 3 courses (6 cycles) of HD IL-2.

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: months
0
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Number of months from start of protocol therapy until death from any cause.
Time Frame Up to 15 months for accrual, plus 6 months of intervention for last subject enrolled, plus 5 years of follow-up (6 years, 9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Bolus Interleukin-2 (HD IL2)
Hide Arm/Group Description:

High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).

The planned treatment consists of 3 courses (6 cycles) of HD IL-2.

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: months
4
4.Secondary Outcome
Title HD IL2 Levels
Hide Description Levels of HD IL2 biomarker in the blood of patients that received at least course 1 of therapy, and have had their disease re-evaluated will be considered evaluable for response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) version 1.1
Time Frame Up to 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
No data displayed because data were not collected for this Outcome Measure, thus zero total participants analyzed.
Arm/Group Title High Dose Bolus Interleukin-2 (HD IL2)
Hide Arm/Group Description:

High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).

The planned treatment consists of 3 courses (6 cycles) of HD IL-2.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From study entry until end of treatment (4 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Dose Bolus Interleukin-2 (HD IL2)
Hide Arm/Group Description

High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).

The planned treatment consists of 3 courses (6 cycles) of HD IL-2.

All-Cause Mortality
High Dose Bolus Interleukin-2 (HD IL2)
Affected / at Risk (%)
Total   1/1 (100.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
High Dose Bolus Interleukin-2 (HD IL2)
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Dose Bolus Interleukin-2 (HD IL2)
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Blood and lymphatic system disorders   
Anemia   1/1 (100.00%)  1
Endocrine disorders   
Hyperthyroidism   1/1 (100.00%)  1
Gastrointestinal disorders   
Nausea   1/1 (100.00%)  1
Vomiting   1/1 (100.00%)  1
General disorders   
Chills   1/1 (100.00%)  1
Fatigue   1/1 (100.00%)  1
Infections and infestations   
Infections and infestations - Other, specify   1/1 (100.00%)  1
Investigations   
Alkaline phosphatase increased   1/1 (100.00%)  1
Blood bilirubin increased   1/1 (100.00%)  1
Creatinine increased   1/1 (100.00%)  1
Investigations - Other, specify   1/1 (100.00%)  1
Lymphocyte count decreased   1/1 (100.00%)  1
Platelet count decreased   1/1 (100.00%)  1
Metabolism and nutrition disorders   
Anorexia   1/1 (100.00%)  1
Hypermagnesemia   1/1 (100.00%)  1
Hypoalbuminemia   1/1 (100.00%)  1
Hypocalcemia   1/1 (100.00%)  1
Hypoglycemia   1/1 (100.00%)  1
Hypomagnesemia   1/1 (100.00%)  1
Hyponatremia   1/1 (100.00%)  1
Hypophosphatemia   1/1 (100.00%)  1
Nervous system disorders   
Nervous system disorders - Other, specify   1/1 (100.00%)  1
Paresthesia   1/1 (100.00%)  1
Psychiatric disorders   
Delirium   1/1 (100.00%)  1
Renal and urinary disorders   
Acute kidney injury   1/1 (100.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea   1/1 (100.00%)  1
Hypoxia   1/1 (100.00%)  1
Pleural effusion   1/1 (100.00%)  1
Vascular disorders   
Hypotension   1/1 (100.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Barbara Stadterman, Regulatory Supervisor
Organization: University of Pittsburgh Cancer Institute
Phone: (412) 647-5554
EMail: stadtermanbm@upmc.edu
Layout table for additonal information
Responsible Party: Ahmad Tarhini, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02796352     History of Changes
Other Study ID Numbers: 15-114
First Submitted: June 6, 2016
First Posted: June 10, 2016
Results First Submitted: February 19, 2018
Results First Posted: April 20, 2018
Last Update Posted: April 20, 2018