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High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer

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ClinicalTrials.gov Identifier: NCT01896271
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : August 23, 2021
Last Update Posted : August 23, 2021
Sponsor:
Collaborator:
Prometheus Laboratories
Information provided by (Responsible Party):
Raquibul Hannan, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Clear Cell Renal Cell Carcinoma
Interventions Drug: IL-2
Radiation: Stereotactic Ablative Body Radiation Therapy
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.

IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions

Period Title: Overall Study
Started 30
Completed 20
Not Completed 10
Reason Not Completed
Physician Decision             10
Arm/Group Title Treatment
Hide Arm/Group Description

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.

IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 30 participants
51.5
(47 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
11
  36.7%
Male
19
  63.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
White
25
  83.3%
Non-white
5
  16.7%
1.Primary Outcome
Title Response Rate
Hide Description Treatment response will be measured using the immune related Response Evaluation Criteria in Solid Tumors (RECIST) criteria (iRECIST) which are a minor modification of RECIST 1.1 for immunotherapy
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 5 patients without measurable disease at baseline and 5 additional patients without 2nd scan to confirm progression. Hence, they were not analyzed.
Arm/Group Title Treatment
Hide Arm/Group Description:

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.

IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
4
  20.0%
2.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival (OS), which is defined as the time between date of registration and the date of death due to any cause.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.

IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions

Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
39
(16 to 53)
3.Secondary Outcome
Title Progression Free Survival
Hide Description Progression Free Survival (PFS), which is defined according to the immune Response Evaluation Criteria in Solid Tumors (iRECIST) as the time between date of registration and the first date of documented disease progression or date of death due to any cause.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
There were 5 patients without measurable disease at baseline and 5 additional patients without 2nd scan to confirm progression. Hence, they were not analyzed.
Arm/Group Title Treatment
Hide Arm/Group Description:

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.

IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions

Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: months
2.5
(2 to 8)
4.Secondary Outcome
Title Time to Progression
Hide Description Time to Progression (TTP), which is defined as time between date of registration and date of documented progression
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was inadvertently added at the time of registration. This is same as progression free survival and measures and reports the exact same thing and is redundant. No separate data was collected from participants for this specific measure.
Arm/Group Title Treatment
Hide Arm/Group Description:

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.

IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Local Control Rate
Hide Description Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of > 20% in tumor size.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.

IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions

Overall Number of Participants Analyzed 30
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
31
Measure Type: Number
Unit of Measure: lesions
30
6.Secondary Outcome
Title Median Response Duration
Hide Description Median response duration, which is defined as the time between the date a response (CR or PR) was first seen until date of progression
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.

IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions

Overall Number of Participants Analyzed 20
Median (Inter-Quartile Range)
Unit of Measure: months
26.7
(11.4 to 36.4)
7.Secondary Outcome
Title Tumor-specific Immune Response
Hide Description Immune response will be measured using ELISpot assay, T-cell proliferation assay and ELISA.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
This data were never collected from the participants.
Arm/Group Title Treatment
Hide Arm/Group Description:

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.

IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Adverse events will be determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.

IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
30
 100.0%
9.Secondary Outcome
Title Health-related Quality of Life (HRQoL).
Hide Description [Not Specified]
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The data were never collected from the participants.
Arm/Group Title Treatment
Hide Arm/Group Description:

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.

IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.

IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions

All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   19/30 (63.33%) 
Hide Serious Adverse Events
Treatment
Affected / at Risk (%)
Total   22/30 (73.33%) 
Blood and lymphatic system disorders   
Hematology Coagulation *  8/30 (26.67%) 
Cardiac disorders   
Cardiac *  3/30 (10.00%) 
Hypotension *  2/30 (6.67%) 
Gastrointestinal disorders   
Gastrointestinal *  1/30 (3.33%) 
General disorders   
Other *  1/30 (3.33%) 
Hepatobiliary disorders   
Hepatobiliary disorders *  3/30 (10.00%) 
Infections and infestations   
Infection *  3/30 (10.00%) 
Nervous system disorders   
Neurologic *  1/30 (3.33%) 
Renal and urinary disorders   
Renal/electrolytes *  11/30 (36.67%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory *  3/30 (10.00%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment
Affected / at Risk (%)
Total   30/30 (100.00%) 
Blood and lymphatic system disorders   
Hematology Coagulation *  28/30 (93.33%) 
Cardiac disorders   
Cardiac *  22/30 (73.33%) 
Hypotension *  18/30 (60.00%) 
Gastrointestinal disorders   
Gastrointestinal *  22/30 (73.33%) 
General disorders   
Constitutional *  27/30 (90.00%) 
Other *  14/30 (46.67%) 
Hepatobiliary disorders   
Hepatobiliary disorders *  19/30 (63.33%) 
Infections and infestations   
Infection *  5/30 (16.67%) 
Nervous system disorders   
Neurologic *  12/30 (40.00%) 
Psychiatric disorders   
Psychiatric *  6/30 (20.00%) 
Renal and urinary disorders   
Renal/electrolytes *  29/30 (96.67%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory *  13/30 (43.33%) 
Skin and subcutaneous tissue disorders   
Skin *  21/30 (70.00%) 
*
Indicates events were collected by non-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: Dr. Raquibul Hannan
Organization: UT Southwestern Medical Center
Phone: 214-645-8525
EMail: Raquibul.Hannan@UTSouthwestern.edu
Layout table for additonal information
Responsible Party: Raquibul Hannan, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01896271    
Other Study ID Numbers: STU 012013-041
First Submitted: July 5, 2013
First Posted: July 11, 2013
Results First Submitted: July 28, 2021
Results First Posted: August 23, 2021
Last Update Posted: August 23, 2021