General Information

Proleukin (aldesleukin) is a human recombinant interleukin-2 product.

Proleukin is specifically indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC) and adults with metastatic melanoma.

Proleukin is supplied as an intravenous infusion. 

The recommended Proleukin (aldesleukin) treatment regimen is administered by a 15-minute intravenous infusion every 8 hours. The following schedule has been used to treat adult patients with metastatic renal cell carcinoma (metastatic RCC) or metastatic melanoma.

Each course of treatment consists of two 5-day treatment cycles separated by a rest period. 600,000 International Units/kg (0.037 mg/kg) dose administered every 8 hours by a 15-minute intravenous infusion for a maximum of 14 doses. Following 9 days of rest, the schedule is repeated for another 14 doses, for a maximum of 28 doses per course, as tolerated. During clinical trials, doses were frequently withheld for toxicity. Metastatic RCC patients treated with this schedule received a median of 20 of the 28 doses during the first course of therapy. Metastatic melanoma patients received a median of 18 doses during the first course of therapy.

Retreatment:  Patients should be evaluated for response approximately 4 weeks after completion of a course of therapy and again immediately prior to the scheduled start of the next treatment course. Additional courses of treatment should be given to patients only if there is some tumor shrinkage following the last course and retreatment is not contraindicated. Each treatment course should be separated by a rest period of at least 7 weeks from the date of hospital discharge.

Side Effects

Adverse effects associated with the use of Proleukin may include, but are not limited to, the following:

• capillary leak syndrome
• flu-like symptoms
• low blood pressure
• decreased kidney and lung function
• respiratory distress
• cardiac abnormalities
• changes in mental status
• edema

The Proleukin drug label comes with the following Black Box Warning: Therapy with Proleukin (aldesleukin) 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.

Clinical Trial Results

In clinical trials of the drug, 16% of 270 patients responded to the drug with half of the patients remaining alive for four years after treatment. Proleukin produced a complete response in 6% of the 270 patients. Approximately 60% of the 17 patients who achieved a complete response have remained in remission for greater that five years without further treatment.