Study on High Dose Interleukin-2 (IL-2) and Targeted Radiation Therapy for Patients with Metastatic Kidney Cancer

Sponsor: Providence Health & Services

Sponsor score: 40

ClinicalTrials ID:NCT02306954

Provider View

This clinical trial is testing a combination of high dose IL-2 therapy and targeted radiation therapy (SBRT) to treat patients with metastatic kidney cancer. The study aims to determine if this approach can effectively manage the disease.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of combining high dose Interleukin-2 (IL-2) therapy with targeted radiation therapy, known as Stereotactic Body Radiation Therapy (SBRT), in treating patients with metastatic kidney cancer. All participants will receive IL-2 treatment, and those showing positive responses may receive additional cycles. Patients in the SBRT group will receive two doses of radiation therapy before starting IL-2 treatment.

Description

In this study, all participants will receive high dose IL-2 therapy, which involves administering IL-2 through an IV every 8 hours for a total of 14 doses. If the cancer responds well, patients may receive up to 6 cycles of IL-2. For those assigned to the SBRT group, two doses of targeted radiation therapy will be given on the Wednesday and Friday before starting IL-2 treatment on Monday. The radiation therapy is aimed at specific tumor sites to enhance the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of clear cell kidney cancer.
  • Must be 18 years or older.
  • Tumors must be suitable for targeted radiation therapy in specific areas like the lungs, chest, bones, or liver, with a maximum of 3 sites treated.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use birth control.
  • Must agree to participate in a patient registry for IL-2 treatment.
  • Must sign a consent form specific to the study.

Exclusion Criteria

  • No tumors suitable for targeted radiation therapy.
  • Have brain metastases that cannot be treated with radiosurgery alone.
  • Have had previous radiation to the proposed treatment sites.
  • Have active infections in the body, lungs, or heart lining.
  • Are pregnant or breastfeeding, due to potential risks to the baby.
  • Show signs of heart problems on specific heart tests.
  • Have significant lung disease as shown by lung function tests.
  • Have blood test results outside the specified range for the study.
  • Require long-term steroid use.

Locations

FACILITYZIPCITYSTATE
Portland Providence Medical Center97213PortlandOregon

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