We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02306954
Recruitment Status : Active, not recruiting
First Posted : December 3, 2014
Last Update Posted : March 24, 2023
Sponsor:
Collaborators:
Prometheus Laboratories
Cytokine Working Group
Information provided by (Responsible Party):
Providence Health & Services

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: High Dose IL-2 Radiation: SBRT Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2014
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306954


Locations
Layout table for location information
United States, Oregon
Portland Providence Medical Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Providence Health & Services
Prometheus Laboratories
Cytokine Working Group
Investigators
Layout table for investigator information
Principal Investigator: Brendan Curti, MD Providence Health & Services
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT02306954    
Other Study ID Numbers: 14-256A
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 2023
Keywords provided by Providence Health & Services:
Kidney Cancer
High Dose IL-2
SBRT
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Aldesleukin
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents