WARNINGS
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.
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PROLEUKIN SUMMARY
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 O) 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.
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NEWS HIGHLIGHTS
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.
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.
Evaluation of Subcutaneous Proleukin (interleukin-2) in a Randomized International Trial (ESPRIT): geographical and gender differences in the baseline characteristics of participants. [2006.03]
CONCLUSION: ESPRIT has enrolled a diverse population of HIV-infected individuals including large populations of women and patients of African-American/African and Asian ethnicity often underrepresented in HIV research. As a consequence, the results of the study may have wide global applicability.
Aldesleukin in advanced renal cell carcinoma. [2004.12]
Renal cell carcinoma accounts for 2-3% of all malignancies.
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.
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.
Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-Risk Melanoma Patients [Recruiting]
The purpose of this study is to see if the combination of the two cancer drugs, Dacarbazine
(DTIC) and a low-dose of Proleukin (IL2), would provide a less toxic and more effective
treatment for melanoma than currently available treatments for people with high-risk
melanoma. Dacarbazine (DTIC) and Proleukin (IL2) are both FDA-approved drugs for the
treatment of melanoma.
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
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Page last updated: 2009-10-20
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