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Background: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects.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

Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102)

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Procedure: One Autologous Transplant
Procedure: Second Autologous Transplant
Procedure: Non-Myeloablative Allogeneic Transplant
Behavioral: Observation
Drug: Thalidomide
Drug: Dexamethasone

First Posted Date: 2004-01-13

Last Posted Date: 2021-11-01

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 710

Registration Number: NCT00075829

Locations: 🇺🇸
DFCI/Brigham & Women's, Boston, Massachusetts, United States
🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
🇺🇸
University of Minnesota, Minneapolis, Minnesota, United States

and more 33 locations

Temozolomide, Thalidomide, and Lomustine in Treating Patients With Unresectable Stage III or Stage IV Melanoma

Phase 2

Completed

Conditions: Intraocular Melanoma
Melanoma (Skin)

First Posted Date: 2003-11-06

Last Posted Date: 2013-01-18

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT00072345

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma

Phase 2

Completed

Conditions: Recurrent Melanoma
Stage IV Melanoma
Tumors Metastatic to Brain

Interventions: Drug: temozolomide
Drug: thalidomide

First Posted Date: 2003-11-06

Last Posted Date: 2013-01-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 50

Registration Number: NCT00072163

Locations: 🇺🇸
Cancer and Leukemia Group B, Chicago, Illinois, United States

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

Phase 2

Terminated

Conditions: Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma

Interventions: Biological: recombinant interferon alfa
Drug: thalidomide
Other: laboratory biomarker analysis

First Posted Date: 2003-10-15

Last Posted Date: 2013-01-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 35

Registration Number: NCT00015912

Locations: 🇺🇸
University of Colorado, Denver, Colorado, United States

Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer

Phase 2

Completed

Conditions: Endometrial Adenoacanthoma
Endometrial Adenocarcinoma
Endometrial Adenosquamous Cell Carcinoma
Endometrial Clear Cell Carcinoma
Endometrial Papillary Serous Carcinoma
Recurrent Endometrial Carcinoma

Interventions: Drug: thalidomide
Other: laboratory biomarker analysis

First Posted Date: 2003-10-15

Last Posted Date: 2013-01-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 60

Registration Number: NCT00025467

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

S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis

Phase 2

Completed

Conditions: Multiple Myeloma
Plasma Cell Myeloma

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

First Posted Date: 2003-07-09

Last Posted Date: 2018-08-09

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 104

Registration Number: NCT00064337

Locations: 🇺🇸
Kalispell Medical Oncology at KRMC, Kalispell, Montana, United States
🇺🇸
Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States
🇺🇸
St. Peter's Hospital, Helena, Montana, United States

and more 31 locations

Interferon Alfa and Thalidomide in Treating Patients With Stage IV Melanoma

Phase 2

Completed

Conditions: Melanoma (Skin)

First Posted Date: 2003-06-25

Last Posted Date: 2013-06-24

Lead Sponsor: SWOG Cancer Research Network

Registration Number: NCT00026520

Locations: 🇺🇸
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, United States
🇺🇸
CCOP - Atlanta Regional, Atlanta, Georgia, United States
🇺🇸
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States

and more 91 locations