Active — Not RecruitingPhase 2

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

United States84 participantsStarted 2014-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Response Rate

Timeframe: 5 years

Trial details

NCT IDNCT02306954

SponsorProvidence Health & Services

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-15

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