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.
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.
Clinical Trials Related to Proleukin (Aldesleukin)
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.
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]
Background:
- 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).
Objectives:
- To compare the effectiveness of adoptive cell therapy with standard high-dose aldesleukin
as a treatment for metastatic melanoma.
Eligibility:
- 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.
Design:
- 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.
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 >>
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