44 Participants Needed

High-dose IL-2 + Radiation Therapy for Melanoma

(SBRT/IL-2 Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Providence Health & Services
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.26789

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.124910

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

SK

Steven K. Seung, M.D.

Principal Investigator

Providence Health & Services

MC

Marka Crittenden, MD, PhD

Principal Investigator

Providence Health & Services

BC

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
See 2 more

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.
See 10 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: SBRT + IL-2Experimental Treatment1 Intervention
Patients will receive two doses of radiation before receiving high-dose IL-2.
Group II: Arm A: IL-2 MonotherapyActive Control1 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.

Find a Clinic Near You

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

Randomized phase II study of stereotactic body radiotherapy and interleukin-2 versus interleukin-2 in patients with metastatic melanoma. [2021]
Radiotherapy and High-Dose Interleukin-2: Clinical and Immunological Results of a Proof of Principle Study in Metastatic Melanoma and Renal Cell Carcinoma. [2022]
High response rate after intratumoral treatment with interleukin-2: results from a phase 2 study in 51 patients with metastasized melanoma. [2010]
High-dose interleukin-2 (IL-2) for the treatment of melanoma: safety considerations and future directions. [2021]
Bolus high dose interleukin-2 for the treatment of malignant melanoma. [2004]
Guidelines for the safe administration of high-dose interleukin-2. [2019]
Toxicity and activity of a twice daily high-dose bolus interleukin 2 regimen in patients with metastatic melanoma and metastatic renal cell cancer. [2011]
Clinical and safety profile of high-dose interleukin-2 treatment in elderly patients with metastatic melanoma and renal cell carcinoma. [2021]
Comparison of acute toxicity and mortality after two different dosing regimens of high-dose interleukin-2 for patients with metastatic melanoma. [2022]
10.United Statespubmed.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]
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