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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Biological: High Dose IL-2
* Radiation: SBRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Dose IL-2<br>Patients will receive IL-2 at 600,000 international units per kg 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 the IL-2 arm who have disease progression after the first two IL-2 cycles have the option to receive SBRT followed by 2 additional cycles of IL-2. | Biological: High Dose IL-2<br>* High Dose IL-2 is approved by the FDA for the treatment of renal cell cancer.<br>* Other names: Proleukin;|
| Experimental: High Dose IL-2 and SBRT<br>Patients assigned to SBRT arm will receive two doses of SBRT at 20 Gy on the Wednesday and Friday before IL-2 starts (the following Monday). Patients will receive IL-2 at 600,000 international units per kg IVB every 8 hours for14 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. | Biological: High Dose IL-2<br>* High Dose IL-2 is approved by the FDA for the treatment of renal cell cancer.<br>* Other names: Proleukin;Radiation: SBRT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | The objective of this study is to compare the response rate among renal cell cancer (RCC) patients of high dose IL-2 to SBRT + IL-2 in patients with metastatic renal cancer | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate in Patients Who Receive SBRT following Progression on IL-2 | Measure the response of SBRT + IL-2 in patients with RCC who have disease progression after high-dose IL-2 | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Cancer, High Dose IL-2, SBRT