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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01896271
Other study ID # STU 012013-041
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2, 2013
Est. completion date April 20, 2021

Study information

Verified date July 2021
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 20, 2021
Est. primary completion date August 25, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: 1. Biopsy-proven metastatic clear cell RCC. 2. Radiographic evidence of metastatic disease. 2.1 Patients with any number of metastatic site are allowed to enroll. However, only up to six sites will be selected for SBRT treatment, at the discretion of the treating radiation oncologist. 3. Patient must have =1 lesion of size >1.5cm. 4. Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed 28 days before the start of HD IL-2 5. Age = 18 years. 6. Performance status ECOG 0, 1. 7. Patient must be eligible for HD IL-2 treatment 8. Patient must be eligible for SABR to one or more extra cranial sites. 9. Adequate organ and marrow function as defined below: - leukocytes = 3,000/mcL - absolute neutrophil count = 1,500/mcL - platelets = 50,000/mcl - total bilirubin = 2mg/dL - AST(SGOT)/ALT(SPGT) = 2.5 X institutional upper limit of normal 10. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 10.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: - Has not undergone a hysterectomy or bilateral oophorectomy; or - Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 11. Ability to understand and the willingness to sign a written informed consent 12. Adequate Renal function with Cr = 1.6 mg/dL. 13. Adequate cardiac function (adequate perfusion; no ischemia) on thallium (or Tc) stress test 14. Adequate pulmonary function on PFT (FEV1 >65%; DLCO>60%). Exclusion Criteria: 1. Subjects who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study 2. History of HIV, Hepatitis B, Hepatitis C and HTLV serology 3. Subjects may not be receiving any other investigational or standard antineoplastic agents. 4. Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis 5. Subjects with life expectancy < 6 months. 6. History of allergic reactions to recombinant IL-2 7. Uncontrolled recurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,. 8. Psychiatric illness/social situations that would limit compliance with study requirements. 9. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. 10. Systemic or topical steroid use or other immunosuppressive therapy within the past 28 days 11. Subjects required to take corticosteroids or other immunosuppressive therapy such as those with organ allograft

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IL-2
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

Locations

Country Name City State
United States University of Texas Southwestern Medical Center Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center Prometheus Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months
Secondary Overall Survival Overall Survival (OS), which is defined as the time between date of registration and the date of death due to any cause. 4 years
Secondary 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. 4 years
Secondary Time to Progression Time to Progression (TTP), which is defined as time between date of registration and date of documented progression 4 years
Secondary 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. 4 years
Secondary 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 4 years
Secondary Tumor-specific Immune Response Immune response will be measured using ELISpot assay, T-cell proliferation assay and ELISA. 4 years
Secondary Number of Participants With Adverse Events Adverse events will be determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. 4 years
Secondary Health-related Quality of Life (HRQoL). 4 years
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