Status:
ACTIVE_NOT_RECRUITING
Study of High Dose Interleukin-2 (IL-2) and Stereotactic Body Radiation (SBRT) in Patients With Metastatic Renal Cancer
Lead Sponsor:
Providence Health & Services
Collaborating Sponsors:
Prometheus Laboratories
Cytokine Working Group
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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. Respond...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT02306954
Start Date
December 1 2014
End Date
December 1 2026
Last Update
March 10 2025
Active Locations (1)
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1
Portland Providence Medical Center
Portland, Oregon, United States, 97213