Study of High Dose Interleukin-2 (IL-2) and Stereotactic Body Radiation (SBRT) in Patients With Metastatic Renal Cancer

March 6, 2025 updated by: Providence Health & Services

Phase II Randomized Study of High Dose Interleukin-2 Versus Stereotactic Body Radiation (SBRT) and High Dose Interleukin-2 (IL-2) in Patients With Metastatic Renal Cancer

All patients will receive IL-2 (14 planned doses with an additional cycle 14 days after the first). Responding patients with regressing disease are eligible for up to 6 IL-2 cycles. Patients assigned to SBRT arm will receive two doses of SBRT on the Wednesday and Friday before the Monday on which IL-2 starts.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients will receive IL-2 at 600,000 international units per kilogram (kg) by intraveneous bolus (IVB) every 8 hours for 14 planned doses with an additional cycle 14 days after the first. Responding patients with regressing disease are eligible for up to 6 IL-2 cycles. Patients assigned to SBRT arm will receive two doses of SBRT at 20 Gray (Gy) on the Wednesday and Friday before the Monday on which IL-2 starts.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97213
        • Portland Providence Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histological confirmation of predominant conventional (clear cell) renal cancer
  • Patients must be ≥ 18 years of age
  • Tumors amenable to SBRT in lungs (central locations preferred), mediastinum, chest wall, bones with a soft tissue component (other than long bones), or liver, liver hilum and associated lymph nodes (inclusive of immediately adjacent masses), 1 - 3 foci; no minimum size, but none greater than 7 cm. Patients may have other metastases but only a maximum of 3 will be treated
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of protocol treatment. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy
  • Patients must agree to participate in the Prometheus IL-2 patient registry (PROCLAIM registry)
  • Patients must sign a study-specific consent form

Exclusion Criteria:

  • No metastatic site amenable to SBRT
  • Patients with brain metastases not candidates for radiosurgery alone
  • Previous radiation to sites proposed for SBRT
  • Patients with active systemic, pulmonary, or pericardial infection
  • Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus
  • Evidence of ischemia on exercise tolerance test, stress thallium study, or baseline EKG
  • Clinically significant underlying pulmonary disease as measured by pulmonary function tests
  • Blood tests within protocol-specified range
  • Need for chronic steroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Dose IL-2

Patients will receive IL-2 at 600,000 international units per kg IVB every 8 hours for 14 planned doses with an additional cycle 14 days after the first. Responding patients with regressing disease are eligible for up to 6 IL-2 cycles.

Patients assigned to the IL-2 arm who have disease progression after the first two IL-2 cycles have the option to receive SBRT followed by 2 additional cycles of IL-2.
Biological: High Dose IL-2
High Dose IL-2 is approved by the FDA for the treatment of renal cell cancer.
Other Names:
  • Proleukin
Experimental: High Dose IL-2 and SBRT
Patients assigned to SBRT arm will receive two doses of SBRT at 20 Gy on the Wednesday and Friday before IL-2 starts (the following Monday). Patients will receive IL-2 at 600,000 international units per kg IVB every 8 hours for14 planned doses with an additional cycle 14 days after the first. Responding patients with regressing disease are eligible for up to 6 IL-2 cycles.
Biological: High Dose IL-2
High Dose IL-2 is approved by the FDA for the treatment of renal cell cancer.
Other Names:
  • Proleukin
Radiation: SBRT
Patients assigned to SBRT arm will receive two doses of SBRT at 20 Gy on the Wednesday and Friday before the Monday on which IL-2 starts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: 5 years
The objective of this study is to compare the response rate among renal cell cancer (RCC) patients of high dose IL-2 to SBRT + IL-2 in patients with metastatic renal cancer
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate in Patients Who Receive SBRT following Progression on IL-2
Time Frame: 5 years
Measure the response of SBRT + IL-2 in patients with RCC who have disease progression after high-dose IL-2
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Providence Health & Services

Collaborators

Prometheus Laboratories
Cytokine Working Group

Investigators

  • Principal Investigator: Brendan Curti, MD, Providence Health & Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

September 15, 2020

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 30, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimated)

December 3, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-256A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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