IL-2 + SBRT for Kidney Cancer

Overseen By Brenda Fisher, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Providence Health & Services

Must not be taking: Chronic steroids

Disqualifiers: Brain metastases, Active infection, Pregnancy, Ischemia, Pulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 6-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of High Dose IL-2, a type of immunotherapy, sometimes combined with targeted radiation (SBRT), for individuals with kidney cancer. Researchers aim to determine if these treatments can shrink tumors and prevent cancer progression. This trial suits those with clear cell kidney cancer and up to three treatable tumor sites in areas such as the lungs or liver. This study may be an option for individuals with kidney cancer interested in exploring new treatment combinations. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you need chronic steroids, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that high-dose IL-2 treatment led to a positive response in 14% to 25% of patients with kidney cancer, meaning their condition improved. However, this treatment can have significant side effects.

Another study found a 20% overall response rate with high-dose IL-2, indicating tumor reduction in some patients. Like many cancer treatments, it reported side effects, including low blood pressure, flu-like symptoms, and organ damage, which vary among patients.

For the SBRT part, research has shown it is generally well-tolerated. In studies with kidney cancer, SBRT has maintained kidney function and presented acceptable levels of side effects, usually not causing severe problems for patients.

Both treatments have been tested in humans before, indicating a level of safety, but they come with risks. Anyone considering joining a trial should discuss these potential side effects and benefits with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for kidney cancer because they combine high dose IL-2 with stereotactic body radiation therapy (SBRT) in a way that could enhance the body's immune response. Unlike standard treatments such as targeted therapies and checkpoint inhibitors, high dose IL-2 works by boosting the immune system's natural ability to fight cancer cells. The addition of SBRT before IL-2 may improve the effectiveness of IL-2 by potentially making tumor cells more recognizable to the immune system. This combination could offer a new approach for patients who don't respond to existing treatments, providing renewed hope in the fight against kidney cancer.

What evidence suggests that this trial's treatments could be effective for kidney cancer?

Research has shown that high-dose IL-2, which participants in this trial may receive, can help treat advanced kidney cancer. Studies indicate that 15% to 25% of patients experience significant tumor shrinkage or complete disappearance.

Another treatment arm in this trial combines high-dose IL-2 with SBRT, a precise radiation therapy. This combination directly targets tumors and boosts the immune system, potentially leading to better outcomes. Although these treatments carry risks, they offer hope for those fighting kidney cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Brendan Curti, MD

Principal Investigator

Providence Health & Services

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patients must sign a study-specific consent form

Patients must agree to participate in the Prometheus IL-2 patient registry (PROCLAIM registry)

My tumor can be targeted with focused radiation due to its size and location.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive high dose IL-2 every 8 hours for 14 planned doses with an additional cycle 14 days after the first. Responding patients may receive up to 6 IL-2 cycles.

6-12 weeks

Multiple visits for IL-2 administration

Radiation

Patients assigned to SBRT arm receive two doses of SBRT at 20 Gy on the Wednesday and Friday before IL-2 starts.

1 week

2 visits for SBRT

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• High Dose IL-2
• SBRT

Trial Overview 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.

How Is the Trial Designed?

Group I: High Dose IL-2 and SBRT Experimental Treatment 2 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-2 Active Control 1 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.

Who Is Running the Clinical Trial?

Providence Health & Services

Lead Sponsor

Trials

131

Recruited

827,000+

Prometheus Laboratories

Industry Sponsor

Trials

27

Recruited

4,800+

Cytokine Working Group

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

High-dose interleukin-2 (HD IL-2) treatment in patients with metastatic renal cell cancer (RCC) resulted in a median survival of 18 months and a 1-year survival rate of 74%, compared to 14 months and 51% for other cytokine therapies.

The study, which reviewed data from 85 patients with a median follow-up of 13 months, indicates that HD IL-2 provides a clinically meaningful improvement in survival outcomes for metastatic RCC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of therapy choice on overall survival in metastatic renal cell carcinoma: a single institution experience. Parmar, S., Rademaker, AW., Fung, BB., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3486432/

High-dose Interleukin-2 for the Treatment of Metastatic Renal ... RESULTS. A total of 23 patients experienced a complete response and 30 patients achieved a partial response, for an overall objective response rate of 20%. All ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10685660/

Long-term survival update for high-dose recombinant ... Median survival time for all 255 patients remains 16.3 months, with 10% to 20% of patients estimated to be alive 5 to 10 years after treatment with high-dose IL ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1558767322000234

Coordinated Pembrolizumab and High Dose IL-2 (5-in-a- ... Single agent objective response rates of 14% to 25% have been reported for usual schedule 14-dose-in-a-row IL-2 therapy of metastatic clear cell renal cancer ( ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e16540

A randomized, open-label, phase II study of high-dose ... A randomized, open-label, phase II study of high-dose interleukin 2 vs high-dose interleukin 2 plus entinostat in renal cell carcinoma.

5. cancernetwork.com cancernetwork.com/view/current-status-interleukin-2-therapy-metastatic-renal-cell-carcinoma-and-metastatic-melanoma

Current Status of Interleukin-2 Therapy for Metastatic Renal ... High-dose IL-2 therapy produces overall response rates of 15% to 20%; however, it is associated with significant toxicities that affect essentially every organ ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.554

Updated efficacy, safety, and correlative analysis of a ... In this abstract, we similarly present extended 6 year follow up results of efficacy, safety, and correlative data from the phase 2 clinical ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5099373/

Contemporary experience with high-dose interleukin-2 ... This analysis includes 170 patients with mM and 192 patients with mRCC treated between 2005 and 2012 with survival data current as of July 27, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00554515

The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients ... To determine, in a prospective fashion, the response rate to high-dose IL-2 for patients with metastatic renal cell carcinoma and "poor" pathologic predictive ...