Study Comparing High-Dose IL-2 Alone and with Radiation Therapy for Metastatic Melanoma

Sponsor: Providence Health & Services

Sponsor score: 40

ClinicalTrials ID:NCT01416831

Provider View

This clinical trial is exploring whether adding radiation therapy to high-dose IL-2 treatment can improve outcomes for patients with metastatic melanoma. The study compares the effects of high-dose IL-2 alone versus high-dose IL-2 combined with radiation therapy.

Patient Parameters

Program Overview

The aim of this study is to see if combining radiation therapy with high-dose IL-2 treatment can improve the response in patients with metastatic melanoma. All participants will receive high-dose IL-2, but half will also receive radiation therapy to up to three tumors before starting IL-2 treatment. Initially, patients receiving radiation will get one dose, but later participants will receive two doses.

Description

In this study, all patients will be treated with high-dose IL-2, a therapy used to boost the immune system's ability to fight cancer. Half of the participants will also receive radiation therapy targeted at up to three tumors before starting IL-2 treatment. For the first 20 patients, those receiving radiation will get one dose, while patients 21-44 will receive two doses. This approach aims to determine if adding radiation can enhance the effectiveness of high-dose IL-2 in treating metastatic melanoma.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of melanoma from a previous biopsy or test.
  • Must be 18 years or older.
  • Must have tumors that can be treated with a specific type of radiation (SBRT) in areas like the lungs, chest, bones (except long bones), or liver, with up to three tumors treated.
  • Must be in good general health, able to carry out normal activities with minimal symptoms (ECOG status 0-1).
  • Women who can become pregnant must have a negative pregnancy test within 72 hours before starting treatment and agree to use birth control. Men must also agree to use birth control.
  • Must sign a consent form specific to this study.

Exclusion Criteria

  • No tumors suitable for the specific radiation treatment (SBRT).
  • Have brain tumors that cannot be treated with radiosurgery.
  • Have had previous radiation to the areas planned for treatment in this study.
  • Have active infections in the body, lungs, or heart lining.
  • Are pregnant or breastfeeding.
  • Show signs of heart problems on certain heart tests.
  • Have significant lung disease affecting breathing tests.
  • Have low white blood cell count, low hemoglobin, or high liver enzymes or bilirubin levels.
  • Have high creatinine levels indicating kidney issues.
  • Require ongoing steroid medication.

Locations

FACILITYZIPCITYSTATE
Providence Cancer Center97213PortlandOregon

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