Isotretinoin

Generic Name: Isotretinoin

Brand Names: Absorica, Accutane, Amnesteem, Claravis, Clarus, Epuris, Myorisan, Sotret, Zenatane

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₈O_₂

CAS Number: 4759-48-2

Unique Ingredient Identifier: EH28UP18IF

Background: Isotretinoin is a retinoid derivative of vitamin A used in the treatment of severe recalcitrant acne. It was most widely marketed under the brand name Accutane, which has since been discontinued. Isotretinoin is associated with major risks in pregnancy and is therefore only available under the iPLEDGE program in the United States. The first isotretinoin-containing product was FDA approved on 7 May 1982.

Indication: Isotretinoin is indicated to treat severe recalcitrant nodular acne and patients ≥12 years enrolled in the iPLEDGE program.

Associated Conditions: Acne conglobata, Neuroblastoma (NB), Rosacea, Sezary Syndrome, Early Mycosis Fungoides (MF), Refractory Acne vulgaris, Severe Recalcitrant nodular acne

Clinical Trials

Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia

Phase 2

Withdrawn

Conditions: Leukemia

First Posted Date: 2004-05-24

Last Posted Date: 2021-10-14

Lead Sponsor: Rush University Medical Center

Registration Number: NCT00003405

Locations: 🇺🇸
Rush-Riverside Cancer Center, Kankakee, Illinois, United States
🇺🇸
Cook County Hospital, Chicago, Illinois, United States
🇺🇸
Rush Cancer Institute, Chicago, Illinois, United States

and more 1 locations

Interferon Alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer

Phase 3

Completed

Conditions: Kidney Cancer

First Posted Date: 2004-05-11

Last Posted Date: 2012-07-11

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 320

Registration Number: NCT00002737

Locations: 🇧🇪
Onze Lieve Vrouw Ziekenhuis Aalst, Aalst, Belgium
🇧🇪
Algemeen Ziekenhuis Middelheim, Antwerp, Belgium
🇳🇱
Groot Ziekengasthuis 's-Hertogenbosch, Hertogenbosch, Netherlands

and more 24 locations

Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia

Phase 1

Completed

Conditions: Chronic Myeloproliferative Disorders
Leukemia
Myelodysplastic Syndromes
Thrombocytopenia

First Posted Date: 2004-04-27

Last Posted Date: 2013-06-26

Lead Sponsor: Drexel University College of Medicine

Registration Number: NCT00003619

Locations: 🇺🇸
Medical College of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
Medical College of Pennsylvania Hospital, Philadelphia, Pennsylvania, United States

Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

First Posted Date: 2004-03-11

Last Posted Date: 2013-07-10

Lead Sponsor: Fox Chase Cancer Center

Target Recruit Count: 17

Registration Number: NCT00021359

Locations: 🇺🇸
Hunterdon Regional Cancer Center, Flemington, New Jersey, United States
🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County, Mount Holly, New Jersey, United States

and more 15 locations

High-Dose Chemotherapy Plus Autologous Stem Cell Transplantation Compared With Intermediate-Dose Chemotherapy Plus Autologous Stem Cell Transplantation With or Without Isotretinoin in Treating Young Patients With Recurrent High-Grade Gliomas

Phase 3

Completed

Conditions: Central Nervous System Tumor
Brain Tumor

Interventions: Biological: filgrastim
Drug: isotretinoin
Drug: carboplatin
Drug: etoposide
Drug: thiotepa
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2004-03-09

Last Posted Date: 2015-05-07

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 1

Registration Number: NCT00078988

Locations: 🇺🇸
Children's Hospital and Health Center - San Diego, San Diego, California, United States
🇺🇸
Indiana University Cancer Center, Indianapolis, Indiana, United States
🇺🇸
Fairview University Medical Center - University Campus, Minneapolis, Minnesota, United States

and more 56 locations

Isotretinoin in Preventing Skin Cancer

Not Applicable

Completed

Conditions: Melanoma (Skin)
Non-melanomatous Skin Cancer

First Posted Date: 2004-02-27

Last Posted Date: 2013-06-19

Lead Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registration Number: NCT00025012

Locations: 🇺🇸
Intramural Research Program, Bethesda, Maryland, United States

Monoclonal Antibody Therapy With Sargramostim and Interleukin-2 in Treating Children With Neuroblastoma

Phase 1

Completed

Conditions: Disseminated Neuroblastoma
Recurrent Neuroblastoma
Regional Neuroblastoma

Interventions: Biological: monoclonal antibody Ch14.18
Drug: isotretinoin
Biological: aldesleukin
Biological: sargramostim

First Posted Date: 2003-11-05

Last Posted Date: 2013-01-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 6

Registration Number: NCT00005576

Locations: 🇺🇸
Children's Oncology Group, Arcadia, California, United States

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Neuroblastoma

Phase 2

Completed

Conditions: Neuroblastoma

Interventions: Biological: filgrastim
Biological: sargramostim
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: etoposide phosphate
Drug: ifosfamide
Drug: isotretinoin
Drug: melphalan
Drug: thiotepa
Drug: vincristine sulfate
Procedure: conventional surgery
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy

First Posted Date: 2003-10-09

Last Posted Date: 2014-02-13

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 42

Registration Number: NCT00017368

Locations: 🇺🇸
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
🇺🇸
Floating Hospital for Children, Boston, Massachusetts, United States
🇺🇸
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States

and more 6 locations

Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma

Phase 1

Completed

Conditions: Neuroblastoma

Interventions: Biological: filgrastim
Drug: cisplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: isotretinoin
Drug: melphalan
Drug: topotecan hydrochloride
Drug: vincristine sulfate
Procedure: conventional surgery
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy

First Posted Date: 2003-10-07

Last Posted Date: 2014-02-13

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 31

Registration Number: NCT00070200

Locations: 🇺🇸
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
🇺🇸
Children's Memorial Hospital - Chicago, Chicago, Illinois, United States
🇦🇺
Westmead Hospital, Westmead, New South Wales, Australia

and more 3 locations

Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Biological: interferon alpha
Drug: 13-cis-retinoic acid
Drug: paclitaxel

First Posted Date: 2003-06-06

Last Posted Date: 2023-07-07

Lead Sponsor: Eastern Cooperative Oncology Group

Target Recruit Count: 37

Registration Number: NCT00062010

Locations: 🇺🇸
CCOP - Columbus, Columbus, Ohio, United States
🇺🇸
Elkhart General Hospital, Elkhart, Indiana, United States
🇺🇸
HealthEast Cancer Care at St. Joseph's Hospital, Saint Paul, Minnesota, United States

and more 70 locations

Drug Development Updates

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