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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

Must not have

Patients with brain metastases not candidates for radiosurgery alone

Need for chronic steroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My brain cancer cannot be treated with radiosurgery alone.

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I need to take steroids regularly for my health condition.

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I have a lung condition that affects my breathing as shown by tests.

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I do not have any ongoing infections.

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I have had radiation therapy on the areas planned for SBRT treatment.

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My cancer has spread, but it can't be treated with focused radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response Rate

Secondary study objectives

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

Diarrhea

Anemia

Shortness of Breath

Abdominal pain

Kidney Injury and/or Infection

Pneumonia

Weight Loss

Dyspnea

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Atrial fibrillation with rapid ventricular response

Pleural effusion

colitis

Thrombocytopenia

Respiratory failure

Skin rash

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met