Thalidomide

Generic Name
Thalidomide
Brand Names
Thalomid, Thalidomide BMS (previously Thalidomide Celgene), Thalidomide Lipomed
Drug Type
Small Molecule
Chemical Formula
C13H10N2O4
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A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects.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
-

Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate

Phase 2
Completed
Conditions
First Posted Date
2004-05-17
Last Posted Date
2012-03-15
Lead Sponsor
National Institutes of Health Clinical Center (CC)
Target Recruit Count
60
Registration Number
NCT00083005
Locations
🇺🇸

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office, Bethesda, Maryland, United States

🇺🇸

NCI - Center for Cancer Research, Bethesda, Maryland, United States

Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma

First Posted Date
2004-05-04
Last Posted Date
2013-03-07
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Registration Number
NCT00008242
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

UARK 2003-33, Total Therapy III

Phase 2
Completed
Conditions
Interventions
First Posted Date
2004-04-29
Last Posted Date
2017-10-17
Lead Sponsor
University of Arkansas
Target Recruit Count
303
Registration Number
NCT00081939
Locations
🇺🇸

University of Arkansas for Medical Sciences/MIRT, Little Rock, Arkansas, United States

An Open Protocol for the Compassionate Use of Thalidomide

Phase 1
Completed
Conditions
First Posted Date
2004-04-22
Last Posted Date
2010-07-02
Lead Sponsor
University of Arkansas
Target Recruit Count
250
Registration Number
NCT00081757
Locations
🇺🇸

University of Arkansas for Medical Sciences/MIRT, Little Rock, Arkansas, United States

Thalidomide in Treating Patients With HIV-Associated Kaposi's Sarcoma

Phase 2
Completed
Conditions
First Posted Date
2004-04-13
Last Posted Date
2013-08-16
Lead Sponsor
National Cancer Institute (NCI)
Registration Number
NCT00019123
Locations
🇺🇸

Medicine Branch, Bethesda, Maryland, United States

Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers

First Posted Date
2004-04-09
Last Posted Date
2013-06-26
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Registration Number
NCT00003754
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

S9922 Combination Chemo Plus Filgrastim With or Without Thalidomide in Refractory Multiple Myeloma

First Posted Date
2004-03-16
Last Posted Date
2015-03-06
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
19
Registration Number
NCT00005834
Locations
🇺🇸

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States

🇺🇸

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

🇺🇸

Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States

and more 90 locations

Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma

Phase 2
Completed
Conditions
First Posted Date
2004-03-09
Last Posted Date
2021-09-09
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
18
Registration Number
NCT00079092
Locations
🇺🇸

CCOP - Central Illinois, Decatur, Illinois, United States

🇺🇸

CCOP - Upstate Carolina, Spartanburg, South Carolina, United States

🇺🇸

CCOP - Greenville, Greenville, South Carolina, United States

and more 2 locations

Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

First Posted Date
2004-03-08
Last Posted Date
2020-04-02
Lead Sponsor
NCIC Clinical Trials Group
Target Recruit Count
67
Registration Number
NCT00006890
Locations
🇺🇸

St. Mary's/Duluth Clinic Health System, Duluth, Minnesota, United States

🇨🇦

Saint John Regional Hospital, Saint John, New Brunswick, Canada

🇨🇦

Moncton Hospital, Moncton, New Brunswick, Canada

and more 61 locations
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