Study of High Dose Interleukin-2 (IL-2) and Stereotactic Body Radiation (SBRT) in Patients With Metastatic Renal Cancer
NCT02306954 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2025-03-10
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.
Conditions
Interventions
- BIOLOGICAL
-
High Dose IL-2
High Dose IL-2 is approved by the FDA for the treatment of renal cell cancer.
- 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.
Sponsors & Collaborators
-
Prometheus Laboratories
collaborator INDUSTRY -
Cytokine Working Group
collaborator OTHER -
Providence Health & Services
lead OTHER
Principal Investigators
-
Brendan Curti, MD · Providence Health & Services
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-12-31
- Primary Completion
- 2020-09-15
- Completion
- 2026-12-31
Countries
- United States
Study Locations
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