High-dose IL-2 + Radiation Therapy for Melanoma

(SBRT/IL-2 Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Providence Health & Services

Must not be taking: Chronic steroids

Disqualifiers: Brain metastases, Active infection, Pregnancy, 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: Unknown

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment for people with metastatic melanoma, a type of skin cancer that has spread to other parts of the body. Researchers aim to determine if adding radiation to high-dose IL-2 therapy (a medicine that boosts the immune system) improves treatment outcomes. The trial compares two groups: one receiving only high-dose IL-2 and another receiving both radiation and IL-2. People with melanoma that has spread to areas like the lungs or liver, who have not had prior radiation to those sites, may be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it does exclude patients who require chronic steroids. It's best to discuss your specific medications with the trial team.

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

Research shows that high-dose IL-2 treatments can be challenging. Common side effects include chills, fever, fatigue, and nausea. Some patients also experience skin rashes and difficulty breathing. When combined with radiation therapy like SBRT (a precise form of radiation treatment), similar side effects are likely.

Studies indicate that most patients experience these side effects, but medical care can usually manage them. This treatment can be intense, so healthcare teams closely monitor patients to manage any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining high-dose IL-2 with radiation therapy for melanoma because it introduces a fresh approach to treatment. Unlike standard therapies like targeted drugs or immunotherapies that work by blocking specific pathways or boosting the immune system, this method uses stereotactic body radiation therapy (SBRT) to potentially prime the immune system before administering IL-2. This combination might enhance the effectiveness of IL-2, offering a more robust attack on cancer cells. By integrating radiation, the hope is to not only directly destroy tumor cells but also stimulate a stronger immune response, potentially leading to improved outcomes for patients.

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

Research has shown that high-dose IL-2, which participants in this trial may receive as monotherapy in Arm A, can help treat metastatic melanoma, a type of skin cancer that has spread. Some studies found that about 14% of patients responded well to IL-2 alone. In Arm B of this trial, participants will receive a combination of high-dose IL-2 and stereotactic body radiation therapy (SBRT). Previous studies demonstrated improved results when IL-2 was combined with SBRT, with 54% of patients responding positively to the combination and 21% showing no signs of cancer afterward. These findings suggest that adding SBRT to high-dose IL-2 could enhance the treatment's effectiveness against melanoma. ^{1 2 3 4 6}

Who Is on the Research Team?

Steven K. Seung, M.D.

Principal Investigator

Providence Health & Services

Marka Crittenden, MD, PhD

Principal Investigator

Providence Health & Services

Brendan Curti, M.D.

Principal Investigator

Providence Health & Services

Are You a Good Fit for This Trial?

This trial is for adults with metastatic melanoma who have up to three tumors suitable for targeted radiation in specific body areas. Women must test negative for pregnancy and agree to prevent conception. Participants need normal heart, lung function tests, and acceptable blood counts. Those with brain metastases not eligible for radiosurgery or previous radiation in the target area cannot join.

Inclusion Criteria

I have confirmed I am not pregnant and will prevent pregnancy during the trial.

My cancer has 1-3 treatable tumors in specific areas, none larger than 7 cm.

Patients must sign a study-specific consent form

Exclusion Criteria

I need to take steroids regularly for my health condition.

Your white blood cell count is less than 3.0 x 10^9 per liter.

My lung function tests are below 70% of what's expected due to lung disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Patients in Arm B receive up to two doses of radiation therapy before high-dose IL-2

1-2 weeks

Treatment

All patients receive high-dose IL-2 therapy, with Arm B receiving it after radiation

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-dose IL-2
• Radiation therapy

Trial Overview The study compares two treatments: one group receives high-dose IL-2 alone, while the other gets both high-dose IL-2 and targeted radiation therapy (SBRT). The goal is to see which treatment better controls metastatic melanoma.

How Is the Trial Designed?

Group I: Arm B: SBRT + IL-2 Experimental Treatment 1 Intervention

Patients will receive two doses of radiation before receiving high-dose IL-2.

Group II: Arm A: IL-2 Monotherapy Active Control 1 Intervention

Patients receive standard high-dose IL-2 therapy, with an opportunity to crossover to the experimental arm if there is disease progression noted after two cycles of high-dose IL-2. Crossover patients will be included in Arm A.

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7259841/

Randomized phase II study of stereotactic body ... The objective response in the SBRT + IL-2 group was 21% CR, 33% PR, 21% SD and 25% PD. Among the patients who received SBRT + IL-2, the best ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01416831

NCT01416831 | Comparison of High-dose IL-2 and ... Study Overview. The purpose of this study is compare the response rates in patients with metastatic melanoma treated with high-dose IL-2 to patients treated ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32467299/

Randomized phase II study of stereotactic body ... We performed a prospective randomized study to determine if the ORR of SBRT + IL-2 was greater than IL-2 monotherapy in patients with advanced melanoma.

4. tcr.amegroups.org tcr.amegroups.org/article/view/6944/html

Immunologic response of combined interleukin-2 and ... The overall response rate in the intent-to-treat analysis was 67%, and was higher among patients with melanoma (71%) compared with RCC (60%). The authors assert ...

5. targetedonc.com targetedonc.com/view/efficacy-and-safety-of-high-dose-interleukin-2-treatment-in-melanoma-patients-with-a-history-of-brain-metastases

Efficacy and Safety of High-Dose Interleukin-2 Treatment in ... Of the 38 patients with BM, 34 (89.5%) were evaluable for response to HD-IL2. The response rate was 11.8%, as compared to a response rate of 14.0% in subjects ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0360301620345934

Toxicity of L19-Interleukin 2 Combined with Stereotactic ... The most frequently reported adverse events were chills, noninfectious fever, fatigue, edema, erythema, pruritus, nausea/vomiting, and cough and dyspnea.