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Cytokine
IL-2 + SBRT for Kidney Cancer
Phase 2
Waitlist Available
Led By Brendan Curti, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be ≥ 18 years of age
Women of childbearing potential must have a negative pregnancy test within 72 hours prior to treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing a new way to treat cancer by combining a drug called IL-2 with a type of radiation called SBRT.
Who is the study for?
This trial is for adults with clear cell renal cancer, who are in good physical condition (ECOG 0-1), not pregnant, and can have specific tumors treated with SBRT. They must consent to join a patient registry and meet certain blood test criteria. Excluded are those with active infections, brain metastases unsuitable for radiosurgery, significant heart or lung issues, or previous radiation where SBRT would be directed.Check my eligibility
What is being tested?
The study tests high dose Interleukin-2 (IL-2) therapy combined with Stereotactic Body Radiation (SBRT). Patients will receive multiple IL-2 doses over several cycles. Those in the SBRT group get two radiation treatments before starting IL-2 to see if this combination improves outcomes compared to IL-2 alone.See study design
What are the potential side effects?
High dose IL-2 can cause flu-like symptoms, low blood pressure, irregular heartbeat, shortness of breath, kidney dysfunction and increased risk of infection. SBRT may result in fatigue, skin reactions at the treatment site and potential damage to nearby organs depending on the location of the radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am a woman who can have children and have a recent negative pregnancy test.
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I am fully active or can carry out light work.
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My kidney cancer is mainly the common type.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response Rate
Secondary outcome measures
Response Rate in Patients Who Receive SBRT following Progression on IL-2
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: High Dose IL-2 and SBRTExperimental Treatment2 Interventions
Patients assigned to SBRT arm will receive two doses of SBRT at 20 Gy on the Wednesday and Friday before IL-2 starts (the following Monday). Patients will receive IL-2 at 600,000 international units per kg IVB every 8 hours for14 planned doses with an additional cycle 14 days after the first. Responding patients with regressing disease are eligible for up to 6 IL-2 cycles.
Group II: High Dose IL-2Active Control1 Intervention
Patients will receive IL-2 at 600,000 international units per kg IVB every 8 hours for 14 planned doses with an additional cycle 14 days after the first. Responding patients with regressing disease are eligible for up to 6 IL-2 cycles.
Patients assigned to the IL-2 arm who have disease progression after the first two IL-2 cycles have the option to receive SBRT followed by 2 additional cycles of IL-2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBRT
2014
Completed Phase 2
~1060
Find a Location
Who is running the clinical trial?
Prometheus LaboratoriesIndustry Sponsor
26 Previous Clinical Trials
4,712 Total Patients Enrolled
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,451 Total Patients Enrolled
Cytokine Working GroupOTHER
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain cancer cannot be treated with radiosurgery alone.You have signs of reduced blood flow to your heart during a stress test or EKG.Your blood test results must be within the specified range outlined in the study guidelines.I need to take steroids regularly for my health condition.My tumor can be targeted with focused radiation due to its size and location.I am 18 years old or older.I am a woman who can have children and have a recent negative pregnancy test.I have a lung condition that affects my breathing as shown by tests.I am fully active or can carry out light work.My kidney cancer is mainly the common type.I do not have any ongoing infections.I have had radiation therapy on the areas planned for SBRT treatment.My cancer has spread, but it can't be treated with focused radiation.
Research Study Groups:
This trial has the following groups:- Group 1: High Dose IL-2
- Group 2: High Dose IL-2 and SBRT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has stereotactic body radiation therapy been sanctioned by the FDA?
"Based on the available evidence, our team at Power rated SBRT's safety as a 2. This is because this medication has seen Phase 2 trials that have generated data supporting its security but no clinical research backing up its efficacy."
Answered by AI
Are there any other precedents to the current research project involving SBRT?
"Currently, 58 experiments are underway to explore the efficacy of SBRT. 4 of these trials have progressed to phase 3 and 396 sites around the US are running them. Moreover, Boston boasts a particularly high concentration of investigations into this treatment modality."
Answered by AI
How many participants have signed on for this clinical research study?
"Unfortunately, no more patients are being accepted for this experiment. Initially posted on December 1st 2014 and lastly modified on January 31st 2022, interested candidates must find other clinical trials. Fortunately, 435 studies related to carcinoma renal cell recruitment remain open, with 58 SBRT trails also admitting participants."
Answered by AI
Is this exploration still enlisting participants?
"This research program has ceased to solicit participants. It was first advertised on December 1st 2014, though the page was last edited on January 31st 2022. If you are seeking alternative trials, there are presently 435 clinical studies in search of patients with carcinoma renal cell and 58 for SBRT actively recruiting individuals."
Answered by AI
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