High-dose IL-2 + Radiation Therapy for Melanoma
(SBRT/IL-2 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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Patients in Arm B receive up to two doses of radiation therapy before high-dose IL-2
Treatment
All patients receive high-dose IL-2 therapy, with Arm B receiving it after radiation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- High-dose IL-2
- Radiation therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Providence Health & Services
Lead Sponsor
Prometheus Laboratories
Industry Sponsor