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Background: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects.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

Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma

Phase 3

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

First Posted Date: 2003-01-27

Last Posted Date: 2013-09-17

Lead Sponsor: Commissie Voor Klinisch Toegepast Onderzoek

Target Recruit Count: 450

Registration Number: NCT00028886

Locations: 🇧🇪
U.Z. Gasthuisberg, Leuven, Belgium
🇳🇱
Isala Klinieken - locatie Sophia, Zwolle, Netherlands
🇳🇱
Academisch Medisch Centrum at University of Amsterdam, Amsterdam, Netherlands

and more 14 locations

Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer

Phase 2

Completed

Conditions: Ovarian Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2013-08-26

Lead Sponsor: Cancer Research UK

Target Recruit Count: 30

Registration Number: NCT00004876

Locations: 🇬🇧
Oxford Radcliffe Hospital, Oxford, England, United Kingdom

S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Biological: filgrastim
Biological: sargramostim
Drug: cyclophosphamide
Drug: dexamethasone
Drug: melphalan
Drug: prednisone
Drug: thalidomide
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2003-01-27

Last Posted Date: 2016-12-08

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 147

Registration Number: NCT00040937

Locations: 🇺🇸
Charles B. Eberhart Cancer Center at DeKalb Medical Center, Decatur, Georgia, United States
🇺🇸
Community Medical Center, Missoula, Montana, United States
🇺🇸
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States

and more 138 locations

Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Interventions: Biological: filgrastim
Biological: recombinant interferon alfa
Drug: busulfan
Drug: cyclophosphamide
Drug: melphalan
Drug: pamidronate disodium
Drug: thalidomide
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2003-01-27

Last Posted Date: 2019-07-02

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 77

Registration Number: NCT00004088

Locations: 🇺🇸
Banner Good Samaritan Medical Center, Phoenix, Arizona, United States
🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States

Thalidomide in Treating Patients With Thyroid Cancer

Phase 2

Completed

Conditions: Head and Neck Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2017-06-06

Lead Sponsor: Kenneth Ain

Registration Number: NCT00026533

Locations: 🇺🇸
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States

Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors
Unspecified Adult Solid Tumor, Protocol Specific

First Posted Date: 2003-01-27

Last Posted Date: 2021-09-09

Lead Sponsor: Wake Forest University Health Sciences

Registration Number: NCT00049361

Locations: 🇺🇸
CCOP - Central Illinois, Decatur, Illinois, United States
🇺🇸
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
🇺🇸
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, United States

and more 2 locations

Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma

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: NCT00047281

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

Thalidomide and Docetaxel in Treating Patients With Advanced Cancer

Phase 1

Completed

Conditions: Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2010-06-11

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 26

Registration Number: NCT00049296

Locations: 🇺🇸
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2003-01-27

Last Posted Date: 2011-10-27

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Target Recruit Count: 26

Registration Number: NCT00039468

Locations: 🇺🇸
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, United States
🇺🇸
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

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