Aldesleukin

Generic Name: Aldesleukin

Brand Names: Proleukin

Drug Type: Biotech

CAS Number: 110942-02-4

Unique Ingredient Identifier: M89N0Q7EQR

Background: Aldesleukin, a lymphokine, is produced by recombinant DNA technology using a genetically engineered E. coli strain containing an analog of the human interleukin-2 gene. Genetic engineering techniques were used to modify the human IL-2 gene, and the resulting expression clone encodes a modified human interleukin-2. This recombinant form differs from native interleukin-2 in the following ways: a) Aldesleukin is not glycosylated because it is derived from E. coli; b) the molecule has no N-terminal alanine; the codon for this amino acid was deleted during the genetic engineering procedure; c) the molecule has serine substituted for cysteine at amino acid position 125.

Indication: For treatment of adults with metastatic renal cell carcinoma.

Associated Conditions: Metastatic Melanoma, Metastatic Renal Cell Carcinoma ( mRCC)

Clinical Trials

High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)

Phase 3

Recruiting

Conditions: Neuroblastoma

Interventions: Drug: Carboplatin
Drug: Vincristine
Drug: Busulfan
Drug: Aldesleukin
Drug: ch14.18/CHO
Drug: Etoposide
Drug: Melphalan
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: G-CSF
Drug: Doxorubicin

First Posted Date: 2012-10-11

Last Posted Date: 2020-10-23

Lead Sponsor: St. Anna Kinderkrebsforschung

Target Recruit Count: 3300

Registration Number: NCT01704716

Locations: 🇵🇱
Medical University in Gdansk, Gdansk, Poland
🇵🇱
Children's University Hospital in Lublin, Lublin, Poland
🇵🇱
University of Medical Sciences Poznan, Poznan, Poland

and more 122 locations

Long Term Continuous Infusion ch14.18/CHO Plus s.c. Aldesleukin (IL-2)

Phase 1

Conditions: Neuroblastoma

Interventions: Drug: ch14.18/CHO
Drug: Isotretinoin
Drug: Aldesleukin

First Posted Date: 2012-10-05

Last Posted Date: 2020-07-14

Lead Sponsor: St. Anna Kinderkrebsforschung

Target Recruit Count: 288

Registration Number: NCT01701479

Locations: 🇪🇸
Hospital Universitario La Fe, Valencia, Spain
🇮🇹
Gaslini Children's Hospital, Genova, Italy
🇫🇷
Institut Gustave Roussy, Villejuif, France

and more 11 locations

Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies

Phase 2

Active, not recruiting

Conditions: Malignant Neoplasm

Interventions: Biological: aldesleukin
Drug: fludarabine phosphate
Drug: cyclophosphamide
Other: laboratory biomarker analysis
Biological: NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL
Biological: dendritic cell vaccine therapy
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography

First Posted Date: 2012-10-02

Last Posted Date: 2024-11-18

Lead Sponsor: Jonsson Comprehensive Cancer Center

Target Recruit Count: 6

Registration Number: NCT01697527

Locations: 🇺🇸
University of California at Los Angeles (UCLA ), Los Angeles, California, United States

CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploid Donor Natural Killer Cell Treatment in Older AML in First Complete Remission

Phase 2

Withdrawn

Conditions: Acute Myelogenous Leukemia

Interventions: Biological: CD3-/CD19- natural killer cells
Biological: CD3-CD56+ natural killer cells
Device: CliniMACS® CD3 and CD19 Reagent System
Device: CliniMACS® CD56 Reagent System
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Aldesleukin

First Posted Date: 2012-07-12

Last Posted Date: 2017-12-02

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Registration Number: NCT01639456

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States

Aerosolized Aldesleukin in Treating Patients With Lung Metastases

Phase 1

Active, not recruiting

Conditions: Metastatic Malignant Neoplasm in the Lung
Metastatic Melanoma
Metastatic Osteosarcoma
Metastatic Renal Cell Cancer
Sarcoma
Stage IV Cutaneous Melanoma AJCC v6 and v7
Stage IV Osteosarcoma AJCC v7
Stage IV Renal Cell Cancer AJCC v7

Interventions: Biological: Aerosolized Aldesleukin
Other: Laboratory Biomarker Analysis

First Posted Date: 2012-05-02

Last Posted Date: 2025-05-13

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 70

Registration Number: NCT01590069

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Vemurafenib and White Blood Cell Therapy for Advanced Melanoma

Phase 1

Terminated

Conditions: Melanoma
Metastatic Cancer

Interventions: Drug: Vemurafenib
Biological: Young TIL
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Aldesleukin

First Posted Date: 2012-04-25

Last Posted Date: 2019-11-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 12

Registration Number: NCT01585415

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Human Papillomavirus-Associated Cancers

Phase 2

Completed

Conditions: Cervical Cancer
Vaginal Cancer
Anal Cancer
Penile Cancer
Oropharyngeal Cancer

Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Biological: Young TIL
Drug: Aldesleukin

First Posted Date: 2012-04-25

Last Posted Date: 2018-03-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 29

Registration Number: NCT01585428

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer

Phase 1

Terminated

Conditions: Pancreatic Cancer
Ovarian Cancer
Lung Cancer
Cervical Cancer
Mesothelioma

Interventions: Drug: Fludarabine
Biological: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Drug: Cyclophosphamide
Drug: Aldesleukin

First Posted Date: 2012-04-24

Last Posted Date: 2019-10-14

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 15

Registration Number: NCT01583686

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Melanoma Treatment With White Blood Cells That Destroy MART Expressing Tumor Cells

Phase 2

Terminated

Conditions: Metastatic Melanoma
Skin Cancer

Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Drug: MART-1 Reactive CD8+ PBL
Drug: Aldesleukin

First Posted Date: 2011-12-20

Last Posted Date: 2015-10-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 5

Registration Number: NCT01495572

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

CAR T Cell Receptor Immunotherapy Targeting EGFRvIII for Patients With Malignant Gliomas Expressing EGFRvIII

Phase 1

Completed

Conditions: Glioblastoma
Malignant Glioma
Brain Cancer
Gliosarcoma

Interventions: Biological: Epidermal growth factor receptor(EGFRv)III Chimeric antigen receptor (CAR) transduced PBL
Drug: Aldesleukin
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2011-10-19

Last Posted Date: 2019-08-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 18

Registration Number: NCT01454596

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

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