High-dose IL-2 + Radiation Therapy for Melanoma
(SBRT/IL-2 Trial)

Recruiting in Palo Alto (17 mi)

Overseen bySteven K. Seung, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Providence Health & Services

No Placebo Group

Prior Safety Data

Trial Summary

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.

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

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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.

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Treatment Details

Interventions

High-dose IL-2 (Cytokine)
Radiation therapy (Radiation)

Trial OverviewThe 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.