Aldesleukin

Generic Name: Aldesleukin

Brand Names: Proleukin

Drug Type: Biotech

Chemical Formula: -

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)

Associated Therapies: -

Clinical Trials

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

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

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

Dose-effect Relationship of Low-dose IL-2 in Type 1 Diabetes

Phase 1

Completed

Conditions: Type 1 Diabetes

Interventions: Drug: Aldesleukin

First Posted Date: 2011-05-16

Last Posted Date: 2012-04-23

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 25

Registration Number: NCT01353833

Locations: 🇫🇷
Hôpital Pitié-Salpêtrière, Paris, France

Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Tumor Infiltrating Lymphocytes Plus IL-2 Following Non-Myeloablative Lymphocyte Depleting Chemo Regimen Alone or in Conjunction With 12Gy Total Body Irradiation (TBI...

Phase 2

Active, not recruiting

Conditions: Metastatic Melanoma
Skin Cancer

Interventions: Drug: Aldesleukin
Drug: Cyclophosphamide
Drug: Fludarabine
Biological: Young TIL
Radiation: Total Body Irradiation (TBI)

First Posted Date: 2011-03-21

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 102

Registration Number: NCT01319565

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

MAGE-A3/12 Metastatic Cancer Treatment With Anti-MAGE-A3/12 TCR-Gene Engineered Lymphocytes

Phase 1

Terminated

Conditions: Metastatic Cancer
Metastatic Renal Cancer
Metastatic Melanoma

Interventions: Biological: PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes
Drug: Aldesleukin
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2011-01-10

Last Posted Date: 2015-10-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 9

Registration Number: NCT01273181

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

Drosophila-generated CTL

Phase 2

Terminated

Conditions: Metastatic Cutaneous Melanoma

Interventions: Drug: fludarabine
Drug: cyclophosphamide
Drug: Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL
Drug: Aldesleukin

First Posted Date: 2011-01-07

Last Posted Date: 2017-08-01

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 3

Registration Number: NCT01271907

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

Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer

Phase 2

Recruiting

Conditions: Metastatic Colorectal Cancer
Metastatic Pancreatic Cancer
Metastatic Ovarian Cancer
Metastatic Breast Carcinoma
Metastatic Endocrine Tumors/ Neuroendocrine Tumors

Interventions: Biological: Young TIL
Drug: Aldesleukin
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Pembrolizumab (Keytruda)

First Posted Date: 2010-08-03

Last Posted Date: 2025-01-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 332

Registration Number: NCT01174121

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

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