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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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 • NCT03004183
21%
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
118 Previous Clinical Trials
822,483 Total Patients Enrolled
Cytokine Working GroupOTHER

Media Library

High Dose IL-2 (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT02306954 — Phase 2
Kidney Cancer Research Study Groups: High Dose IL-2, High Dose IL-2 and SBRT
Kidney Cancer Clinical Trial 2023: High Dose IL-2 Highlights & Side Effects. Trial Name: NCT02306954 — Phase 2
High Dose IL-2 (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02306954 — Phase 2
~3 spots leftby Dec 2024
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