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
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Clear Cell Renal Cell Carcinoma||Drug: IL-2 Radiation: Stereotactic Ablative Body Radiation Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Metastatic Clear Cell Renal Cell Cancer (mRCC)|
|Actual Study Start Date :||October 2, 2013|
|Actual Primary Completion Date :||August 25, 2020|
|Actual Study Completion Date :||April 20, 2021|
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.
HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion
Radiation: Stereotactic Ablative Body Radiation Therapy
SABR dose varying from 8Gy-20Gy in 1-3 fractions
Other Name: SABR, SBRT
- Response Rate [ Time Frame: 6 months ]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
- Overall Survival [ Time Frame: 4 years ]Overall Survival (OS), which is defined as the time between date of registration and the date of death due to any cause.
- Progression Free Survival [ Time Frame: 4 years ]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 to Progression [ Time Frame: 4 years ]Time to Progression (TTP), which is defined as time between date of registration and date of documented progression
- Local Control Rate [ Time Frame: 4 years ]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.
- Median Response Duration [ Time Frame: 4 years ]Median response duration, which is defined as the time between the date a response (CR or PR) was first seen until date of progression
- Tumor-specific Immune Response [ Time Frame: 4 years ]Immune response will be measured using ELISpot assay, T-cell proliferation assay and ELISA.
- Number of Participants With Adverse Events [ Time Frame: 4 years ]Adverse events will be determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
- Health-related Quality of Life (HRQoL). [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896271
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Raquibul Hannan, MD, PhD||University of Texas Southwestern Medical Center|