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Proleukin (Aldesleukin) - Summary



Therapy with PROLEUKIN ® (aldesleukin) for injection should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and form al 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 c are 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 s evere 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 seps is and bacterial endocarditis. Consequently, preexisting bacterial infections should be adequately treated prior to in itiation 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.



PROLEUKIN® (aldesleukin) for injection, a human recombinant interleukin-2 product, is a highly purified protein with a molecular weight of approximately 15,300 daltons.

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

PROLEUKIN is indicated for the treatment of adults with metastatic melanoma.

Careful patient selection is mandatory prior to the administration of PROLEUKIN. See “ CONTRAINDICATIONS ”, “ WARNINGS ” and “ PRECAUTIONS ” sections regarding patient screening, including recommended cardiac and pulmonary function tests and laboratory tests.

Evaluation of clinical studies to date reveals that patients with more favorable ECOG performance status (ECOG PS 0) at treatment initiation respond better to PROLEUKIN, with a higher response rate and lower toxicity (see “ CLINICAL PHARMACOLOGY ” section, “ Clinical Experience ” subsection and “ ADVERSE REACTIONS ” section). Therefore, selection of patients for treatment should include assessment of performance status.

Experience in patients with ECOG PS >1 is extremely limited.

See all Proleukin indications & dosage >>


Published Studies Related to Proleukin (Aldesleukin)

The evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial: rationale, design, and methods of ESPRIT. [2002.04]
The Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) is a large ongoing randomized trial of subcutaneous interleukin-2 (IL-2) plus antiretroviral therapy versus antiretroviral therapy alone in patients with HIV (human immunodeficiency virus) disease and CD4 cell counts of at least 300 cells/mm(3)...

Clinical and immunologic effects of intranodal autologous tumor lysate-dendritic cell vaccine with Aldesleukin (Interleukin 2) and IFN-{alpha}2a therapy in metastatic renal cell carcinoma patients. [2009.08.01]
CONCLUSIONS: The clinical and immunologic responses observed in this trial suggest an interaction between DC vaccination and cytokine therapy. Our data support the hypothesis that modulation of inflammatory, regulatory, and angiogenic pathways are necessary to optimize therapeutic benefit in renal cell carcinoma patients. Further exploration of this approach is warranted.

The high-dose aldesleukin (IL-2) "select" trial: a trial designed to prospectively validate predictive models of response to high-dose IL-2 treatment in patients with metastatic renal cell carcinoma. [2009.08]
For patients with metastatic renal cell carcinoma (RCC), the prognosis is poor... This review article discusses a phase II trial that investigates predictive biomarkers that might help clinicians identify the patient population with metastatic RCC that would benefit from IL-2 therapy and therefore limit patients who receive this toxic therapy to those most likely to benefit.

Immunity feedback and clinical outcome in colon cancer patients undergoing chemoimmunotherapy with gemcitabine + FOLFOX followed by subcutaneous granulocyte macrophage colony-stimulating factor and aldesleukin (GOLFIG-1 Trial). [2008.07.01]
CONCLUSIONS: Our results suggest that immunity feedback to GOLFIG regimen and its antitumor activity are tightly correlated.

[Clinical study on recombinant human interleukin-2 (Proleukin) in the treatment of metastatic renal cell carcinoma] [2008.02]
OBJECTIVE: To evaluate the efficacy and safety of subcutaneous injection of recombinant human interleukin-2 (Proleukin) in the treatment of metastatic renal cell carcinoma (RCC)... CONCLUSION: Subcutaneous injection of recombinant human interleukin-2 may prolong the survival of patients with a metastatic renal cell carcinoma. This regimen is tolerable with rare severe toxicities.

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Clinical Trials Related to Proleukin (Aldesleukin)

Toxicity Substudy of Evaluation of Subcutaneous Proleukin in a Randomised International Trial (ESPRIT): TOXIL-2 Substudy [Recruiting]
This substudy is an open-label, randomised study comparing the uptake of recombinant interleukin-2 (rIL-2) in HIV-1 infected individuals receiving different combinations of antiemetics and analgesic agents during rIL-2 dosing in ESPRIT. The design is a factorial one with 4 arms. All patients will receive regular ibuprofen and paracetamol from days 1-6 of the rIL-2 dosing cycle; in addition, patients will be randomised to receive one of two antiemetic combinations, i. e. ondansetron or metoclopramide with or without low dose codeine phosphate as an additional analgesic agent.

Prospective Randomized Comparative Study of Cell Transfer Therapy Using CD8+-Enriched Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen Compared to High-Dose Aldesleukin in M... [Recruiting]

- Adoptive cell therapy involves taking white blood cells called lymphocytes from patients'

tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient to allow the cells to attack the tumor. Because this process is lengthy and difficult to perform, researchers have been developing improved means of performing adoptive cell therapy. Researchers are now interested in comparing adoptive cell therapy with the standard treatment for metastatic melanoma (skin cancer).


- To compare the effectiveness of adoptive cell therapy with standard high-dose aldesleukin

as a treatment for metastatic melanoma.


- Individuals 18 years of age or older who have been diagnosed with metastatic melanoma

and have not previously received aldesleukin therapy or cell therapy for their disease.

- Participants must have at least one tumor that can be easily removed as part of the

treatment procedure.


- Participants will be screened with a full medical history, physical examination, blood

and urine tests, and imaging scans to evaluate tumor size and treatment options.

- Participants will be separated into two groups, in which one group will have adoptive

cell therapy and one will have aldesleukin treatment.

- Adoptive Cell Therapy

- Participants will have a tumor sample taken in order to collect white blood cells

for treatment. Participants whose tumors do not provide sufficient white blood cells may be switched to the aldesleukin-only treatment group.

- The white blood cells will be grown in the laboratory for several weeks.

- Prior to receiving cell therapy, participants will receive chemotherapy for 7 days

to improve the chances of successful treatment.

- Participants will have cell therapy followed by high-dose aldesleukin treatment

every 8 hours for up to 5 days. This treatment will be followed by 1 to 2 weeks of recovery time as an inpatient at the clinical center.

- Participants will be evaluated at 12 weeks following the start of the study, every

2 to 3 months for the first year, every 6 months for the next 5years, and then yearly thereafter..

- Standard Aldesleukin Treatment

- Participants will have high-dose aldesleukin treatment every 8 hours for up to 5

days (one cycle of treatment), and will have a second cycle of treatment 7 to 10 days after the first cycle.

- If tests show that the tumors have grown, participants will be offered the chance

to have additional cycles of aldesleukin, or begin a cell therapy treatment.

- Participants will be evaluated at 12 weeks following the start of the study, every 2 to

3 months for the first year, every 6 months for the next 5years, and then yearly thereafter.

Aldesleukin in Patients With Metastatic Renal Cell Carcinoma and Metastatic Melanoma [Recruiting]
This study will evaluate the pharmacokinetics of aldesleukin in patients with metastatic renal cell cancer and metastatic melanoma

A Phase I Study of the Safety of Proleukin (Aldesleukin) in Combination With Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis [Completed]
To determine the MTD and dose-limiting toxicities of a regimen of therapeutic ganciclovir, antiretroviral therapy, and recombinant interleukin-2 (aldesleukin; Proleukin) as an immune adjuvant in HIV-seropositive patients. To investigate the effect of increasing doses of Proleukin on the time to progression of CMV retinitis in patients being treated with therapeutic ganciclovir and antiretroviral therapy. To evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient population.

A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients [Completed]
To determine the MTD and dose-limiting toxicities of recombinant interleukin-2 (aldesleukin; Proleukin) administered subcutaneously in HIV-seropositive patients. To identify a tolerable subcutaneous regimen that will replicate the immunologic improvement demonstrated in the outpatient polyethylene glycolated IL-2 and high-dose continuous infusion IL-2 studies. To evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient population.

more trials >>

Reports of Suspected Proleukin (Aldesleukin) Side Effects

Neoplasm Progression (7)Hypotension (6)Unresponsive TO Stimuli (5)Dyspnoea (5)Infection (4)Mental Status Changes (4)Tachycardia (3)Oedema Peripheral (3)Oedema (3)Pleural Effusion (3)more >>

Page last updated: 2010-10-05

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