PROLEUKIN Clinical Trials Data

Before the United States Food and Drug Administration (FDA) approves a drug for treatment of a particular disease or condition, the drug must be studied under controlled scientific conditions. These studies are called clinical trials. During the clinical trials, patients are treated with the drug, and the effectiveness in treating the disease is measured. Patients are also carefully monitored for potential side effects that may be caused by the treatment.

The results of clinical trials are submitted to the FDA to determine whether the drug should be approved for use.

When considering treatment options with your doctor, it's important to understand how results are measured in clinical trials and what they mean to your disease. For cancer treatments, most results are measured by how much a tumor has changed after a specific period of treatment.

Results of early PROLEUKIN Clinical Trials

Metastatic Renal Cell Carcinoma (metastatic kidney cancer)
Year received FDA Approval	1992
Number of Patients	255 patients
Number of Trials	7
Response	In 15% of the patients, the tumors shrank or disappeared as a result of PROLEUKIN therapy. In 8% of all patients' tumors shrank. In 7% of all patients' tumors disappeared.
Results	For the 7% of all patients who had a complete response (all tumors disappeared), those patients remained cancer-free for a median duration of at least 6.7 years. For more detailed results, please see full prescribing information.

Metastatic Melanoma
Year received FDA Approval	1998
Number of Patients	270 patients
Number of Trials	8
Response	In 16% of the patients, tumors shrank or disappeared as a result of PROLEUKIN therapy. In 10% of all patients tumors shrank. In 6% of all patients tumors disappeared.
Results	For the 8% of patients whose tumors completely disappeared from the treatment, they remained cancer-free for a median duration of at least 4.9 years. For more detailed results, please see full prescribing information.

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PROLEUKIN Product Information Line 1-877-378-4919.

PROLEUKIN (aldesleukin) is indicated for the treatment of adults with metastatic
renal cell carcinoma and metastatic melanoma.

Important Safety Information

Therapy with PROLEUKIN^® (aldesleukin) for injection should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing. Extreme caution should be used in patients with a normal thallium stress test and a normal pulmonary function test who have a history of cardiac or pulmonary disease.

PROLEUKIN^® should be administered in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.

PROLEUKIN^® administration has been associated with capillary leak syndrome (CLS) which is characterized by a loss of vascular tone, and extravasation of plasma proteins and fluid into the extravascular space. CLS results in hypotension and reduced organ perfusion which may be severe and can result in death. CLS may be associated with cardiac arrhythmias (supraventricular and ventricular), angina, myocardial infarction, respiratory insufficiency requiring intubation, gastrointestinal bleeding or infarction, renal insufficiency, edema, and mental status changes.

PROLEUKIN^® treatment is associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Consequently, preexisting bacterial infections should be adequately treated prior to initiation of PROLEUKIN^® therapy. Patients with indwelling central lines are particularly at risk for infection with gram positive microorganisms. Antibiotic prophylaxis with oxacillin, nafcillin, ciprofloxacin, or vancomycin has been associated with a reduced incidence of staphylococcal infections.

PROLEUKIN^® administration should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma.

IMPORTANT Side Effect Information

In clinical studies, the following life-threatening side effects were seen in >1% of 525 patients (255 with metastatic renal cell cancer and 270 with metastatic melanoma) treated with PROLEUKIN: decreased urine (6%), stopping of all urine (5%), low blood pressure (3%), breathing problems (3%), abnormal blood test (high bilirubin) for how the liver works (2%), coma (2%), diarrhea (2%), too many acid chemicals in the blood (1%), sudden kidney failure (1%), stopping breathing (1%), heart problems (1%), clotting problems (1%), confusion (1%), abnormal blood test (high creatinine) for how the kidney works (1%), shortness of breath (1%), fever (1%), heart attack (1%), infection (1%), severe mental illness (1%), infection in the blood (1%), abnormal blood test (high SGOT) for how the liver works (1%), severe sleepiness (1%), fast heartbeat (2%), low blood platelet count increasing the chance of bleeding (1%), and vomiting (1%).

From the same studies, the following side effects (Grades 1-4, meaning from mild to severe) were seen in >30% of 525 patients (255 with metastatic renal cell cancer and 270 with metastatic melanoma) treated with PROLEUKIN: low blood pressure (71%), diarrhea (67%), decreased urine (63%), chills (52%), vomiting (50%), shortness of breath (43%), rash (42%), abnormal blood test (high bilirubin) for how the liver works (40%), low blood platelet count increasing the chance of bleeding (37%), nausea (35%), confusion (34%), and abnormal blood test (high creatinine) for how the kidney works (33%).

In patients receiving PROLEUKINin these studies (255 with metastatic renal cell carcinoma and 270 with metastatic melanoma), 4% (11/255) of patients with metastatic renal cell cancer and 2% (6/270) of patients with metastatic melanoma died from treatment-related side effects of PROLEUKIN.

Please see complete prescribing information, including boxed warning.

The content contained in this website is not intended to be a substitute for professional medical advice related to any topic discussed. Patients are urged to consult with their treating physicians or other professionals. Never disregard professional, medical or legal advice or delay seeking such advice because of something you have read on this website.

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