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

Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

Phase 3

Active, not recruiting

Conditions: Recurrent Neuroblastoma
Regional Neuroblastoma
Stage 4S Neuroblastoma
Stage 4 Neuroblastoma
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma

Interventions: Drug: Isotretinoin
Biological: Aldesleukin
Other: Laboratory Biomarker Analysis
Biological: Dinutuximab
Other: Pharmacological Study
Other: Quality-of-Life Assessment
Biological: Sargramostim

First Posted Date: 2003-01-27

Last Posted Date: 2025-01-03

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1449

Registration Number: NCT00026312

Locations: 🇺🇸
Rady Children's Hospital - San Diego, San Diego, California, United States
🇺🇸
UCSF Medical Center-Parnassus, San Francisco, California, United States
🇺🇸
UCSF Medical Center-Mission Bay, San Francisco, California, United States

and more 194 locations

Interleukin-2 (IL-2) Treatment for HIV Infected Patients Who Have Interrupted Their Anti-HIV Drug Therapy

Not Applicable

Completed

Conditions: HIV Infections

First Posted Date: 2002-05-30

Last Posted Date: 2021-11-01

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 21

Registration Number: NCT00038259

Locations: 🇺🇸
Univ. of Hawaii at Manoa, Leahi Hosp., Honolulu, Hawaii, United States
🇺🇸
UCLA CARE Center CRS, Los Angeles, California, United States
🇺🇸
UC Davis Medical Center, Sacramento, California, United States

and more 7 locations

The Safety and Effectiveness of Interleukin-2 Plus Zidovudine in Patients With AIDS or AIDS Related Complex

Phase 1

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2021-11-04

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 18

Registration Number: NCT00000986

Locations: 🇺🇸
Univ of Pittsburgh Med School, Pittsburgh, Pennsylvania, United States

A Phase I Study of Autologous, Activated CD8(+) Lymphocytes Expanded In Vitro and Infused With or Without Recombinant Interleukin-2 to Patients With AIDS or Severe ARC

Phase 1

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2021-11-02

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 6

Registration Number: NCT00000680

Locations: 🇺🇸
Univ of Pittsburgh Med School, Pittsburgh, Pennsylvania, United States

A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy

Phase 2

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2021-10-28

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 104

Registration Number: NCT00000820

Locations: 🇺🇸
Alabama Therapeutics CRS, Birmingham, Alabama, United States
🇺🇸
University of Colorado Hospital CRS, Aurora, Colorado, United States
🇺🇸
SUNY - Buffalo, Erie County Medical Ctr., Buffalo, New York, United States

and more 7 locations

A Study to Evaluate the Use of a Protease Inhibitor and of Interleukin-2 (IL-2) in the Treatment of Early HIV Infection

Phase 3

Completed

Conditions: HIV Infections

Interventions: Drug: Indinavir sulfate
Drug: Ritonavir
Drug: Efavirenz
Drug: Abacavir sulfate
Drug: Stavudine
Drug: Didanosine
Drug: Aldesleukin

First Posted Date: 2001-08-31

Last Posted Date: 2013-09-06

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 165

Registration Number: NCT00006154

Locations: 🇨🇦
Centre Hospitalier de la Universite de Montreal (CHUM), Montreal, Quebec, Canada
🇨🇦
Centre de traitment d'immunodeficience, Montreal, Quebec, Canada
🇨🇦
Viridae Clinical Sciences / University of British Columbia, Vancouver, British Columbia, Canada

and more 1 locations

Treatment With Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328

Not Applicable

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2012-05-21

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 110

Registration Number: NCT00000923

Locations: 🇺🇸
St. Louis ConnectCare, Infectious Diseases Clinic, St Louis, Missouri, United States
🇺🇸
Harbor-UCLA Med. Ctr. CRS, Torrance, California, United States
🇺🇸
Case CRS, Cleveland, Ohio, United States

and more 9 locations

A Study of Zidovudine Plus Interleukin-2 in HIV-Infected Patients Who Have No Symptoms of Infection But Who Have Tender Lymph Nodes

Phase 1

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2021-11-04

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 30

Registration Number: NCT00001005

Locations: 🇺🇸
Duke Univ. Med. Ctr. Adult CRS, Durham, North Carolina, United States

A Study to Evaluate the Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3

Phase 2

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2021-10-29

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 72

Registration Number: NCT00000889

Locations: 🇦🇷
Hospital F.J. Muniz C601-050 CRS, Ciudad de Buenos Aires, Buenos Aires, Argentina
🇦🇷
Hospital Italiano de Buenos Aires C601-020 CRS, Ciudad de Buenos Aires, Buenos Aires, Argentina
🇦🇷
Hospital de Clinicas 'Jose de San Martin' C601-040 CRS, Ciudad de Buenos Aires, Buenos Aires, Argentina

and more 1 locations

Effectiveness of Adding Interleukin-2 to Anti-HIV Drugs in Patients Recently Infected With HIV

Not Applicable

Completed

Conditions: HIV Infections

Interventions: Drug: Lamivudine/Zidovudine
Drug: Nelfinavir mesylate
Drug: Aldesleukin

First Posted Date: 2001-08-31

Last Posted Date: 2015-03-09

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 398

Registration Number: NCT00006441

Locations: 🇺🇸
University of Alabama- Birmingham, Birmingham, Alabama, United States
🇺🇸
Rick Hecht, San Francisco, California, United States

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