NCT02306954Active, not recruitingPhase 2
Study of High Dose Interleukin-2 (IL-2) and Stereotactic Body Radiation (SBRT) in Patients With Metastatic Renal Cancer
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 30 Nov 2014
- Start date
- Dec 2014
- Primary completion date
- 15 Sept 2020
- Lead sponsor
- Providence Health & Services
- Diseases
- Kidney cancer
- NCT number
- NCT02306954
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 84
- From Dec 2014 to the primary completion date, 15 Sept 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiation to sites proposed for SBRT
- Need for chronic steroids
Other illness
- Patients with active systemic, pulmonary, or pericardial infection
- Clinically significant underlying pulmonary disease as measured by pulmonary function tests
Other
- No metastatic site amenable to SBRT
- Patients with brain metastases not candidates for radiosurgery alone
- 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
- Blood tests within protocol-specified range
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Portland Providence Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.