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-cont...

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

Associated Therapies: -

Clinical Trials

Observation, Combination Chemotherapy, Radiation Therapy, and/or Autologous Stem Cell Transplant in Treating Young Patients With Neuroblastoma

Phase 3

Conditions: Neuroblastoma

First Posted Date: 2006-12-13

Last Posted Date: 2013-08-07

Lead Sponsor: German Society for Pediatric Oncology and Hematology GPOH gGmbH

Target Recruit Count: 642

Registration Number: NCT00410631

Locations: 🇩🇪
Kinderklinik - Universitaetsklinikum Aachen, Aachen, Germany
🇩🇪
Klinikum Dortmund, Dortmund, Germany
🇩🇪
Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl, Cologne, Germany

and more 74 locations

Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET

Phase 3

Active, not recruiting

Conditions: Anaplastic Medulloblastoma
Medulloblastoma

Interventions: Procedure: Biospecimen Collection
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Procedure: Lumbar Puncture
Biological: Filgrastim
Drug: Isotretinoin
Procedure: Magnetic Resonance Imaging
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Drug: Vincristine Sulfate

First Posted Date: 2006-10-26

Last Posted Date: 2024-01-26

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 379

Registration Number: NCT00392327

Locations: 🇺🇸
Inova Fairfax Hospital, Falls Church, Virginia, United States
🇺🇸
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
🇵🇷
University Pediatric Hospital, San Juan, Puerto Rico

and more 182 locations

Belinostat and Isotretinoin in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery

Phase 1

Completed

Conditions: Adult Solid Neoplasm

Interventions: Drug: Belinostat
Drug: Isotretinoin
Other: Pharmacological Study

First Posted Date: 2006-06-08

Last Posted Date: 2018-04-03

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 51

Registration Number: NCT00334789

Locations: 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 2 locations

Vorinostat and Isotretinoin in Treating Patients With Advanced Kidney Cancer

Phase 1

Terminated

Conditions: Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer

Interventions: Drug: vorinostat
Drug: isotretinoin

First Posted Date: 2006-05-11

Last Posted Date: 2021-02-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 14

Registration Number: NCT00324740

Locations: 🇺🇸
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
🇺🇸
Weill Medical College of Cornell University, New York, New York, United States

Vorinostat With or Without Isotretinoin in Treating Young Patients With Recurrent or Refractory Solid Tumors, Lymphoma, or Leukemia

Phase 1

Completed

Conditions: Childhood Acute Promyelocytic Leukemia (M3)
Childhood Atypical Teratoid/Rhabdoid Tumor
Childhood Burkitt Lymphoma
Childhood Chronic Myelogenous Leukemia
Childhood Diffuse Large Cell Lymphoma
Childhood Immunoblastic Large Cell Lymphoma
Juvenile Myelomonocytic Leukemia
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Childhood Grade III Lymphomatoid Granulomatosis

Interventions: Drug: vorinostat
Drug: isotretinoin

First Posted Date: 2005-09-22

Last Posted Date: 2014-06-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 60

Registration Number: NCT00217412

Locations: 🇺🇸
Children's Oncology Group, Philadelphia, Pennsylvania, United States

Isotretinoin, Interferon Alfa-2b, Docetaxel, and Estramustine in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

Phase 2

Terminated

Conditions: Prostate Cancer

First Posted Date: 2005-09-15

Last Posted Date: 2009-12-11

Lead Sponsor: University of Medicine and Dentistry of New Jersey

Target Recruit Count: 40

Registration Number: NCT00176527

Locations: 🇺🇸
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer

Phase 2

Terminated

Conditions: Cervical Cancer

Interventions: Biological: recombinant interferon alpha-2b
Drug: isotretinoin
Drug: paclitaxel

First Posted Date: 2005-08-30

Last Posted Date: 2013-11-20

Lead Sponsor: University of Medicine and Dentistry of New Jersey

Target Recruit Count: 33

Registration Number: NCT00138151

Locations: 🇺🇸
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
UMDNJ University Hospital, Newark, New Jersey, United States
🇺🇸
Carol G. Simon Cancer Center at Morristown Memorial Hospital, Morristown, New Jersey, United States

and more 3 locations

Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors
Glioblastoma Multiforme

Interventions: Drug: Celecoxib
Drug: Isotretinoin
Drug: Temozolomide
Drug: Thalidomide

First Posted Date: 2005-06-03

Last Posted Date: 2021-10-18

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 178

Registration Number: NCT00112502

Locations: 🇺🇸
CCOP - Atlanta Regional, Atlanta, Georgia, United States
🇺🇸
CCOP - Central Illinois, Decatur, Illinois, United States
🇺🇸
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

and more 9 locations

MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas

Phase 1

Completed

Conditions: Adult Grade III Lymphomatoid Granulomatosis
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma

Interventions: Drug: entinostat
Drug: isotretinoin

First Posted Date: 2004-12-09

Last Posted Date: 2013-01-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 24

Registration Number: NCT00098891

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

Podocyte Retinoids

Phase 2

Completed

Conditions: Glomerulosclerosis, Focal Segmental
Collapsing Glomerulopathy

Interventions: Drug: Isotretinoin

First Posted Date: 2004-12-02

Last Posted Date: 2017-12-13

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Target Recruit Count: 12

Registration Number: NCT00098020

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

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