Metastatic Clear Cell Renal Cell CarcinomaPhase 2NCT01896271
High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer
A Phase 2 study testing IL-2 and Stereotactic Ablative Body Radiation Therapy in people with Metastatic Clear Cell Renal Cell Carcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Metastatic Clear Cell Renal Cell Carcinoma
- What is being tested?
- IL-2 and Stereotactic Ablative Body Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2013to 20 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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).
- Ability to understand and the willingness to sign a written informed consent
- Adequate Renal function with Cr ≤ 1.6 mg/dL.
- Adequate cardiac function (adequate perfusion; no ischemia) on thallium (or Tc) stress test
- Adequate pulmonary function on PFT (FEV1 >65%; DLCO>60%).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
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)
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
- Being tested
- IL-2, Stereotactic Ablative Body Radiation Therapy
- Keywords
- kidney cancer, metastatic cancer
- Medical subject headings
- Clear-cell metastatic renal cell carcinoma, Kidney Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-2Drug
HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion
Stereotactic Ablative Body Radiation TherapyRadiation
Also called SABR, SBRT
SABR dose varying from 8Gy-20Gy in 1-3 fractions
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | 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. Receives: Drug: IL-2; Radiation: Stereotactic Ablative Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (8)
Overall Survival
Overall Survival (OS), which is defined as the time between date of registration and the date of death due to any cause.
Measured: 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.
Measured: 4 years
Time to Progression
Time to Progression (TTP), which is defined as time between date of registration and date of documented progression
Measured: 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.
Measured: 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
Measured: 4 years
Tumor-specific Immune Response
Immune response will be measured using ELISpot assay, T-cell proliferation assay and ELISA.
Measured: 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.
Measured: 4 years
Health-related Quality of Life (HRQoL).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study start2 Oct 2013
- Primary completion25 Aug 2020
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Prometheus Laboratories
- Responsible party
- Principal investigator, Raquibul Hannan, University of Texas Southwestern Medical Center
- Investigators
- Raquibul Hannan, MD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896271
- Sponsor's protocol ID
- STU 012013-041
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2013
- Last updated
- 23 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01896271
- Acronym / sponsor ID
- STU 012013-041
- Keywords
- kidney cancer, metastatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Prometheus Laboratories
- Study start
- 2 Oct 2013 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Posted 23 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: IL-2, Radiation: Stereotactic Ablative Body Radiation TherapyHD 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL-2HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion | Drug | treatment |
| Stereotactic Ablative Body Radiation TherapyAlso: SABR, SBRTSABR dose varying from 8Gy-20Gy in 1-3 fractions | Radiation | treatment |
Primary outcome
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
8 secondary outcomes
Overall Survival
Time frame: 4 years
Progression Free Survival
Time frame: 4 years
Time to Progression
Time frame: 4 years
Local Control Rate
Time frame: 4 years
Median Response Duration
Time frame: 4 years
Tumor-specific Immune Response
Time frame: 4 years
Number of Participants With Adverse Events
Time frame: 4 years
Health-related Quality of Life (HRQoL).
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquibul Hannan, MD, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IL-2 and Stereotactic Ablative Body Radiation Therapy in people with Metastatic Clear Cell Renal Cell Carcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.