In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically when immediately followed by the non-specific immune stimulation provided by treatment with HD IL-2 and thereby increase the response rate and complete response for metastatic clear cell renal cell cancer patients. Both HD IL-2 and SABR are FDA approved therapeutic cancer treatment
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Response Rate
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
Overall Survival
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
Progression Free Survival
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
Time to Progression
Time to Progression (TTP), which is defined as time between date of registration and date of documented progression
Time frame: 4 years
Local Control Rate
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
Median Response Duration
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
Tumor-specific Immune Response
Immune response will be measured using ELISpot assay, T-cell proliferation assay and ELISA.
Time frame: 4 years
Number of Participants With Adverse Events
Adverse events will be determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Time frame: 4 years
Health-related Quality of Life (HRQoL).
Time frame: 4 years
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