Kidney Cancer Clinical Trial

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

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.

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Full 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.

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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

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

84

Study ID:

NCT02306954

Recruitment Status:

Active, not recruiting

Sponsor:

Providence Health & Services

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There is 1 Location for this study

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Portland Providence Medical Center
Portland Oregon, 97213, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

84

Study ID:

NCT02306954

Recruitment Status:

Active, not recruiting

Sponsor:


Providence Health & Services

How clear is this clinincal trial information?

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