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Background: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects.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

Clinical Trials

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

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

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

Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Colorectal Cancer

Interventions: Drug: thalidomide
Procedure: adjuvant therapy
Other: Placebo

First Posted Date: 2003-01-27

Last Posted Date: 2015-10-28

Lead Sponsor: National Institutes of Health Clinical Center (CC)

Target Recruit Count: 39

Registration Number: NCT00019747

Locations: 🇺🇸
Suburban Hospital Cancer Program, Bethesda, Maryland, United States
🇺🇸
Center for Cancer Care at Goshen Health System, Goshen, Indiana, United States
🇺🇸
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

and more 3 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 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

Interferon Alfa-2b With or Without Thalidomide in Treating Patients With Metastatic or Unresectable Kidney Cancer

Phase 3

Completed

Conditions: Kidney Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2009-02-05

Lead Sponsor: Eastern Cooperative Oncology Group

Registration Number: NCT00005966

Locations: 🇵🇪
Instituto de Enfermedades Neoplasicas, Lima, Peru
🇺🇸
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, United States

and more 11 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

Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy

Phase 2

Completed

Conditions: Prostate Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2013-04-04

Lead Sponsor: Nuvance Health

Registration Number: NCT00046826

Locations: 🇺🇸
Whittingham Cancer Center at Norwalk Hospital, Norwalk, Connecticut, United States
🇺🇸
Carl and Dorothy Bennett Cancer Center at Stamford Hospital, Stamford, Connecticut, 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

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