High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer
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)
1 other identifier
interventional
30
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2013
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2013
CompletedFirst Posted
Study publicly available on registry
July 11, 2013
CompletedStudy Start
First participant enrolled
October 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2021
CompletedResults Posted
Study results publicly available
August 23, 2021
CompletedAugust 23, 2021
July 1, 2021
6.9 years
July 5, 2013
July 28, 2021
July 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Overall Survival
4 years
Progression Free Survival
4 years
Time to Progression
4 years
Local Control Rate
4 years
Median Response Duration
4 years
- +3 more secondary outcomes
Study Arms (1)
treatment
EXPERIMENTALHD 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.
Interventions
SABR dose varying from 8Gy-20Gy in 1-3 fractions
Eligibility Criteria
You may qualify if:
- Biopsy-proven metastatic clear cell RCC.
- 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.
- Patient must have ≥1 lesion of size \>1.5cm.
- Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed 28 days before the start of HD IL-2
- Age ≥ 18 years.
- Performance status ECOG 0, 1.
- Patient must be eligible for HD IL-2 treatment
- Patient must be eligible for SABR to one or more extra cranial sites.
- 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
- 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.
- +7 more criteria
You may not qualify if:
- Subjects who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
- History of HIV, Hepatitis B, Hepatitis C and HTLV serology
- Subjects may not be receiving any other investigational or standard antineoplastic agents.
- Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis
- Subjects with life expectancy \< 6 months.
- History of allergic reactions to recombinant IL-2
- Uncontrolled recurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Systemic or topical steroid use or other immunosuppressive therapy within the past 28 days
- Subjects required to take corticosteroids or other immunosuppressive therapy such as those with organ allograft
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Raquibul Hannan
- Organization
- UT Southwestern Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Raquibul Hannan, MD, PhD
University of Texas Southwestern Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 5, 2013
First Posted
July 11, 2013
Study Start
October 2, 2013
Primary Completion
August 25, 2020
Study Completion
April 20, 2021
Last Updated
August 23, 2021
Results First Posted
August 23, 2021
Record last verified: 2021-07