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Background: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects.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

Associated Therapies: -

Clinical Trials

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

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

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

Thalidomide With or Without Fludarabine in Treating Patients With Hematologic Cancer

Phase 2

Terminated

Conditions: Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia

Interventions: Drug: thalidomide
Drug: fludarabine phosphate

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 70

Registration Number: NCT00009984

Locations: 🇺🇸
Montefiore Medical Center, Bronx, New York, United States

Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Phase 2

Completed

Conditions: Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Small Lymphocytic Lymphoma

Interventions: Drug: thalidomide
Other: laboratory biomarker analysis

First Posted Date: 2003-01-27

Last Posted Date: 2013-01-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 45

Registration Number: NCT00022581

Locations: 🇺🇸
Cancer and Leukemia Group B (CALGB) Research Base, Chicago, Illinois, United States

Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

Phase 2

Completed

Conditions: B-cell Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia

Interventions: Drug: thalidomide
Other: laboratory biomarker analysis

First Posted Date: 2003-01-27

Last Posted Date: 2013-10-08

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 41

Registration Number: NCT00006226

Locations: 🇺🇸
North Central Cancer Treatment Group, Rochester, Minnesota, United States

Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

First Posted Date: 2003-01-27

Last Posted Date: 2014-04-04

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT00033332

Locations: 🇺🇸
Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania, United States
🇺🇸
CCOP - Scott and White Hospital, Temple, Texas, United States
🇺🇸
Veterans Affairs Medical Center - Madison, Madison, Wisconsin, United States

and more 75 locations

Thalidomide Plus Interferon Alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed

Phase 2

Completed

Conditions: Liver Cancer

Interventions: Biological: recombinant interferon alfa
Drug: thalidomide

First Posted Date: 2003-01-27

Last Posted Date: 2013-02-11

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 38

Registration Number: NCT00006006

Locations: 🇺🇸
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
🇺🇸
Mount Sinai School of Medicine, New York, New York, United States

Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus

Phase 2

Completed

Conditions: Recurrent Uterine Corpus Sarcoma
Uterine Corpus Leiomyosarcoma

Interventions: Drug: Thalidomide
Other: Laboratory Biomarker Analysis

First Posted Date: 2003-01-27

Last Posted Date: 2019-07-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 60

Registration Number: NCT00025220

Locations: 🇺🇸
Gynecologic Oncology Group, Philadelphia, Pennsylvania, United States

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