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

Primary Purpose

Renal Cell Carcinoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
High Dose IL-2
SBRT
Sponsored by
Providence Health & Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Kidney Cancer, High Dose IL-2, SBRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Portland Providence Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

High Dose IL-2

High Dose IL-2 and SBRT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Response Rate
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

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

Full Information

First Posted
November 30, 2014
Last Updated
March 23, 2023
Sponsor
Providence Health & Services
Collaborators
Prometheus Laboratories, Cytokine Working Group
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1. Study Identification

Unique Protocol Identification Number
NCT02306954
Brief Title
Study of High Dose Interleukin-2 (IL-2) and Stereotactic Body Radiation (SBRT) in Patients With Metastatic Renal Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Providence Health & Services
Collaborators
Prometheus Laboratories, Cytokine Working Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Kidney Cancer, High Dose IL-2, SBRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Dose IL-2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High Dose IL-2 and SBRT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
High Dose IL-2
Other Intervention Name(s)
Proleukin
Intervention Description
High Dose IL-2 is approved by the FDA for the treatment of renal cell cancer.
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response Rate
Description
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
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Response Rate in Patients Who Receive SBRT following Progression on IL-2
Description
Measure the response of SBRT + IL-2 in patients with RCC who have disease progression after high-dose IL-2
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brendan Curti, MD
Organizational Affiliation
Providence Health & Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Portland Providence Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States

12. IPD Sharing Statement

Links:
URL
http://oregon.providence.org/our-services/p/providence-cancer-center/
Description
Providence Cancer Center

Learn more about this trial

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

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