Thalidomide

Generic Name: Thalidomide

Brand Names: Thalomid, Thalidomide BMS (previously Thalidomide Celgene), Thalidomide Lipomed

Drug Type: Small Molecule

Chemical Formula: C_₁₃H_₁₀N_₂O_₄

CAS Number: 50-35-1

Unique Ingredient Identifier: 4Z8R6ORS6L

Background: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of inflammatory disorders and cancers. Thalidomide displays immunosuppressive and anti-angiogenic activity through modulating the release of inflammatory mediators like tumor necrosis factor-alpha (TNF-a) and other cytokine action. Due to severe teratogenicity, pregnancy must be excluded before the start of treatment and patients must enrol in the THALIDOMID Risk Evaluation and Mitigation Strategy (REMS) program to ensure contraception adherence.

Indication: Thalidomide is primarily used for the acute treatment and maintenance therapy to prevent and suppress the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).

Associated Conditions: Aphthous Stomatitis, Chronic Graft-Versus-Host Disease, Erythema Nodosum Leprosum, Multiple Myeloma (MM), Primary Amyloidosis, Uremic Pruritus, Waldenström's Macroglobulinemia (WM), Moderate Erythema nodosum leprosum, Refractory Graft versus host disease, Severe Erythema nodosum leprosum, Treatment naive multiple myeloma

Clinical Trials

Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-24

Lead Sponsor: California Cancer Consortium

Registration Number: NCT00022607

Locations: 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
🇺🇸
University of Chicago Cancer Research Center, Chicago, Illinois, United States

and more 1 locations

Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma

Phase 2

Conditions: Sarcoma

First Posted Date: 2003-01-27

Last Posted Date: 2014-01-06

Lead Sponsor: Herbert Irving Comprehensive Cancer Center

Registration Number: NCT00033709

Locations: 🇺🇸
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States

Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery

Phase 2

Completed

Conditions: Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer

Interventions: Drug: thalidomide
Drug: doxorubicin hydrochloride
Other: laboratory biomarker analysis

First Posted Date: 2003-01-27

Last Posted Date: 2015-04-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 75

Registration Number: NCT00006016

Locations: 🇺🇸
New York University Langone Medical Center, New York, New York, United States

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

Phase 2

Conditions: Kidney Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2013-08-07

Lead Sponsor: Cancer Research UK

Target Recruit Count: 90

Registration Number: NCT00027664

Locations: 🇬🇧
Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom
🇬🇧
Oxford Radcliffe Hospital, Oxford, England, United Kingdom
🇬🇧
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

Thalidomide in Treating Patients With Asymptomatic, Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Phase 1

Completed

Conditions: Leukemia
Lymphoma

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-26

Lead Sponsor: Beth Israel Deaconess Medical Center

Registration Number: NCT00052416

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States

Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Interventions: Drug: prednisone
Drug: thalidomide

First Posted Date: 2003-01-27

Last Posted Date: 2023-09-13

Lead Sponsor: NCIC Clinical Trials Group

Target Recruit Count: 332

Registration Number: NCT00049673

Locations: 🇨🇦
Tom Baker Cancer Centre, Calgary, Alberta, Canada
🇨🇦
London Regional Cancer Program, London, Ontario, Canada
🇨🇦
Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario, Canada

and more 15 locations

Radiation Therapy With or Without Thalidomide in Treating Patients With Brain Metastases

Phase 3

Completed

Conditions: Tumors Metastatic to Brain

Interventions: Radiation: radiation therapy
Drug: thalidomide
Procedure: quality-of-life assessment

First Posted Date: 2003-01-27

Last Posted Date: 2020-10-30

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 332

Registration Number: NCT00033254

Locations: 🇺🇸
Radiation Therapy Oncology Group, Philadelphia, Pennsylvania, United States

Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2003-01-27

Last Posted Date: 2017-07-11

Lead Sponsor: Dana-Farber Cancer Institute

Registration Number: NCT00047294

Locations: 🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 1 locations

A Study to Access the Safety/Efficacy of Thalidomide in the Treatment of Anemia in Patients With Myelodysplastic Syndromes

Phase 3

Completed

Conditions: Myelodysplastic Syndromes

First Posted Date: 2002-12-24

Last Posted Date: 2005-06-24

Lead Sponsor: Celgene Corporation

Target Recruit Count: 220

Registration Number: NCT00050843

Locations: 🇺🇸
Beaumont Cancer Center, Royal Oak, Michigan, United States
🇺🇸
Texas Oncology PA-BMT Center, Dallas, Texas, United States
🇺🇸
Northwest Medical Specialists, Arlington Heights, Illinois, United States

and more 35 locations

A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus

Phase 2

Completed

Conditions: Discoid Lupus Erythematosus

First Posted Date: 2002-12-10

Last Posted Date: 2008-03-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 17

Registration Number: NCT00001680

Locations: 🇺🇸
National Cancer Institute (NCI), Bethesda, Maryland, United States

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