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Background: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects.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

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

Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Phase 3

Completed

Conditions: Primary Peritoneal Cavity Cancer
Stage III Ovarian Epithelial Cancer
Recurrent Ovarian Epithelial Cancer
Fallopian Tube Cancer
Stage IV Ovarian Epithelial Cancer

Interventions: Drug: thalidomide
Drug: tamoxifen citrate
Other: laboratory biomarker analysis

First Posted Date: 2003-01-27

Last Posted Date: 2019-07-30

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 139

Registration Number: NCT00041080

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

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

Phase 2

Completed

Conditions: Uterine Carcinosarcoma
Recurrent Uterine Corpus Sarcoma

Interventions: Other: Laboratory Biomarker Analysis
Drug: Thalidomide

First Posted Date: 2003-01-27

Last Posted Date: 2019-07-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 55

Registration Number: NCT00025506

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

Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer

Phase 3

Terminated

Conditions: Lung Cancer

Interventions: Drug: carboplatin
Drug: paclitaxel
Radiation: radiation therapy
Drug: thalidomide

First Posted Date: 2003-01-27

Last Posted Date: 2014-06-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 589

Registration Number: NCT00004859

Locations: 🇺🇸
Sletten Regional Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States
🇺🇸
Doctors Hospital at Ohio Health, Columbus, Ohio, United States
🇺🇸
Swedish Covenant Hospital, Chicago, Illinois, United States

and more 230 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