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

44 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment High-dose IL-2 + Radiation Therapy for Melanoma?

Research shows that combining high-dose IL-2 with radiation therapy can lead to a higher response rate in patients with metastatic melanoma compared to IL-2 alone. Additionally, this combination treatment has been found to be well tolerated and immunologically active, suggesting it could be a promising strategy for patients who have not responded to standard treatments. ^{1 2 3 4 5}

Is high-dose IL-2 combined with radiation therapy safe for humans?

High-dose IL-2 has been used safely in humans for treating metastatic melanoma and renal cell carcinoma, though it can cause side effects like low blood pressure and requires careful management. When combined with radiation therapy, it was generally well tolerated, with most side effects being mild to moderate in severity. ^{2 6 7 8 9}

How does the treatment of high-dose IL-2 combined with radiation therapy differ from other treatments for melanoma?

The combination of high-dose IL-2 with radiation therapy for melanoma is unique because it leverages the immune-boosting effects of IL-2 with the cancer-killing and immune-modulating effects of radiation. This approach aims to enhance the body's immune response against melanoma, potentially offering benefits for patients who have not responded to standard treatments. ^{1 2 4 9 10}

What is the purpose of this trial?

The purpose of this study is compare the response rates in patients with metastatic melanoma treated with high-dose IL-2 to patients treated with high-dose IL-2 along with radiation therapy.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Randomized phase II study of stereotactic body radiotherapy and interleukin-2 versus interleukin-2 in patients with metastatic melanoma. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Radiotherapy and High-Dose Interleukin-2: Clinical and Immunological Results of a Proof of Principle Study in Metastatic Melanoma and Renal Cell Carcinoma. [2022]

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

High response rate after intratumoral treatment with interleukin-2: results from a phase 2 study in 51 patients with metastasized melanoma. [2010]

4. England pubmed.ncbi.nlm.nih.gov

High-dose interleukin-2 (IL-2) for the treatment of melanoma: safety considerations and future directions. [2021]

5. Israel pubmed.ncbi.nlm.nih.gov

Bolus high dose interleukin-2 for the treatment of malignant melanoma. [2004]

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

Guidelines for the safe administration of high-dose interleukin-2. [2019]

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

Toxicity and activity of a twice daily high-dose bolus interleukin 2 regimen in patients with metastatic melanoma and metastatic renal cell cancer. [2011]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical and safety profile of high-dose interleukin-2 treatment in elderly patients with metastatic melanoma and renal cell carcinoma. [2021]

9. France pubmed.ncbi.nlm.nih.gov

Comparison of acute toxicity and mortality after two different dosing regimens of high-dose interleukin-2 for patients with metastatic melanoma. [2022]

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

Randomized phase III trial of treatment with high-dose interleukin-2 either alone or in combination with interferon alfa-2a in patients with advanced melanoma. [2018]