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

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

All patients will receive IL-2 (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 SBRT arm will receive two doses of SBRT on the Wednesday and Friday before the Monday on which IL-2 starts.

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 the combination of IL-2 and SBRT safe for treating kidney cancer?

High-dose interleukin-2 (IL-2) has been used in treating kidney cancer, but it can cause significant side effects like low blood pressure, breathing difficulties, and neurological issues. While these studies don't specifically mention SBRT, they highlight the potential risks of IL-2, which may be relevant when combined with other treatments. ^{1 2 3 4 5}

How does the treatment IL-2 + SBRT for kidney cancer differ from other treatments?

The IL-2 + SBRT treatment for kidney cancer is unique because it combines high-dose interleukin-2 (IL-2), which can produce long-lasting responses in some patients, with stereotactic body radiation therapy (SBRT), which may enhance the effectiveness of IL-2. This combination aims to improve outcomes by potentially increasing the body's immune response to cancer cells. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment IL-2 + SBRT for Kidney Cancer?

High-dose interleukin-2 (IL-2) has been shown to produce long-lasting responses in a small number of patients with metastatic kidney cancer, and combining it with radiation therapy has been found to enhance its effect in experimental models. ^{2 6 7 8 9}

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. United States pubmed.ncbi.nlm.nih.gov

Update on the application of interleukin-2 in the treatment of renal cell carcinoma. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Implications of therapy choice on overall survival in metastatic renal cell carcinoma: a single institution experience. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Phase II trial of sequential radiation and interleukin 2 in the treatment of patients with metastatic renal cell carcinoma. [2004]

4. United States pubmed.ncbi.nlm.nih.gov

Interleukin-2 therapy of metastatic renal cell carcinoma--predictors of response. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Interleukin-2 therapy of metastatic renal cell carcinoma: update of phase III trials. [2007]

6. Germany pubmed.ncbi.nlm.nih.gov

A phase II trial of dose-intensive interleukin-2 in metastatic renal cell carcinoma. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Phase I study of subcutaneously administered interleukin-2 in combination with interferon alfa-2a in patients with advanced cancer. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A phase 2 study of moderate dose interleukin-2 and granulocyte-macrophage colony-stimulating factor in patients with metastatic or unresectable renal cell carcinoma. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

A phase I study of high-dose interleukin-2 in combination with interferon-alpha 2b. [2018]