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Methotrexate

Generic Name
Methotrexate
Brand Names
Metoject, Nordimet, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep, Jylamvo
Drug Type
Small Molecule
Chemical Formula
C20H22N8O5
CAS Number
59-05-2
Unique Ingredient Identifier
YL5FZ2Y5U1
Background

Methotrexate is a folate derivative that inhibits several enzymes responsible for nucleotide synthesis. This inhibition leads to suppression of inflammation as well as prevention of cell division. Because of these effects, methotrexate is often used to treat inflammation caused by arthritis or to control cell division in neoplastic diseases such as breast cancer and non-Hodgkin's lymphoma.

Due to the toxic effects of methotrexate, it is indicated for treatment of some forms of arthritis and severe psoriasis only if first line treatment has failed or patients are intolerant of those treatments.

Methotrexate was granted FDA approval on 7 December 1953.

Indication

Methotrexate oral solution is indicated for pediatric acute lymphoblastic leukemia and pediatric polyarticular juvenile idiopathic arthritis. Methotrexate injections for subcutaneous use are indicated for severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and severe, recalcitrant, disabling psoriasis.

Other formulations are indicated to treat gestational choriocarcinoma, chorioadenoma destruens, hydatiform mole, breast cancer, epidermoid cancer of the head and neck, advanced mycosis fungoides, lung cancer, and advanced non-Hodgkin's lymphoma. It is also used in the maintenance of acute lymphocytic leukemia. Methotrexate is also given before treatment with leucovorin to prolong relapse-free survival following surgical removal of a tumour in non-metastatic osteosarcoma.

Associated Conditions
Acute Lymphoblastic Leukemia (ALL), Acute Promyelocytic Leukemia, Bladder Cancer, Breast Cancer, Central Nervous System Lymphoma, Crohn's Disease (CD), Dermatomyositis (DM), Extrauterine Pregnancy, Gestational Trophoblastic Neoplasia, Graft-versus-host Disease (GVHD), Meningeal leukemia, Multiple Sclerosis, Mycosis Fungoides (MF), Non-Hodgkin's Lymphoma (NHL), Non-Hodgkin's Lymphoma, Relapsed, Osteosarcoma, Polyarticular Juvenile Idiopathic Arthritis, Polymyositis, Rheumatoid Arthritis, Soft Tissue Sarcoma, Squamous Cell Carcinoma of the Head and Neck (SCCHN), Systemic Lupus Erythematosus, Uveitis, Nonleukemic meningeal cancer, Refractory Non-Hodgkin's lymphoma, Refractory Takayasu arteritis, Severe Psoriasis
Associated Therapies
Medically induced abortion

Multicenter Randomized Prospective Trial Comparing Methotrexate Alone or in Combination With Adalimumab in Early Arthritis

Phase 4
Conditions
Rheumatoid Arthritis
Arthritis
First Posted Date
2006-02-15
Last Posted Date
2006-02-15
Lead Sponsor
Goupe d'Etudes et de Recherche Clinique En Rhumatologie
Target Recruit Count
80
Registration Number
NCT00291915
Locations
🇫🇷

Hopital Cochin, Paris, France

Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma

First Posted Date
2006-02-13
Last Posted Date
2020-09-23
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
55
Registration Number
NCT00290433
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

Phase 2
Conditions
Brain and Central Nervous System Tumors
First Posted Date
2006-02-07
Last Posted Date
2013-09-17
Lead Sponsor
Children's Cancer and Leukaemia Group
Target Recruit Count
29
Registration Number
NCT00287924
Locations
🇬🇧

Addenbrooke's Hospital, Cambridge, England, United Kingdom

🇬🇧

Southampton General Hospital, Southampton, England, United Kingdom

🇬🇧

Royal Manchester Children's Hospital, Manchester, England, United Kingdom

and more 17 locations

Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma

Phase 2
Completed
Conditions
Lymphoma, Non-Hodgkin
First Posted Date
2006-01-31
Last Posted Date
2013-02-28
Lead Sponsor
University Hospital, Limoges
Target Recruit Count
40
Registration Number
NCT00283985
Locations
🇫🇷

Service d'Hématologie, Evry, France

🇫🇷

Département Maladies du Sang, Angers, France

🇫🇷

CH Annecy, Annecy, France

and more 22 locations

A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Rituximab
Drug: Methotrexate
Biological: Tetanus toxoid adsorbed booster vaccine
Drug: Methylprednisone
Biological: C. albicans
Biological: 23-valent pneumococcal polysaccharide vaccine
Biological: Keyhole limpet hemocyanin
First Posted Date
2006-01-26
Last Posted Date
2017-08-10
Lead Sponsor
Genentech, Inc.
Target Recruit Count
103
Registration Number
NCT00282308
Locations
🇺🇸

Evanston Northwestern Healthcare, Evanston, Illinois, United States

🇺🇸

Borgess Research Institute, Kalamazoo, Michigan, United States

🇺🇸

Justus Fiechtner MD - PP, Lansing, Michigan, United States

and more 31 locations

Combination Chemotherapy With or Without Radiation Therapy in Treating Children With Brain Tumors

Phase 2
Conditions
Brain and Central Nervous System Tumors
Neuroblastoma
First Posted Date
2006-01-25
Last Posted Date
2013-09-20
Lead Sponsor
Children's Cancer and Leukaemia Group
Target Recruit Count
50
Registration Number
NCT00281905
Locations
🇮🇪

Our Lady's Hospital for Sick Children, Dublin, Ireland

🇬🇧

Birmingham Children's Hospital, Birmingham, England, United Kingdom

🇬🇧

Royal Liverpool Children's Hospital, Alder Hey, Liverpool, England, United Kingdom

and more 17 locations

Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer

Phase 2
Terminated
Conditions
Unusual Cancers of Childhood
Chronic Myeloproliferative Disorders
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Leukemia
Lymphoma
Interventions
Biological: filgrastim
Biological: anti-thymocyte globulin
Drug: cyclophosphamide
Drug: busulfan
Drug: carmustine
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: methotrexate
Drug: cytarabine
Drug: mycophenolate mofetil
Drug: etoposide
Drug: methylprednisolone
Drug: tacrolimus
Drug: melphalan
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Procedure: umbilical cord blood transplantation
First Posted Date
2006-01-25
Last Posted Date
2017-09-27
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
200
Registration Number
NCT00281879
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

Fludarabine and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Chronic Lymphocytic Leukemia or Waldenstrom's Macroglobulinemia

Phase 1
Completed
Conditions
Chronic Lymphocytic Leukemia
Interventions
Biological: alemtuzumab
Biological: anti-thymocyte globulin
Biological: filgrastim
Biological: rituximab
Biological: therapeutic allogeneic lymphocytes
Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: methotrexate
Drug: mycophenolate mofetil
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
First Posted Date
2006-01-25
Last Posted Date
2017-07-24
Lead Sponsor
German CLL Study Group
Target Recruit Count
100
Registration Number
NCT00281983
Locations
🇩🇪

Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin, Germany

🇩🇪

University Hospital of Leipzig, Leipzig, Germany

🇩🇪

Klinikum der Universitaet Regensburg, Regensburg, Germany

and more 10 locations

Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas

First Posted Date
2006-01-18
Last Posted Date
2013-12-19
Lead Sponsor
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Target Recruit Count
150
Registration Number
NCT00278278
Locations
🇺🇸

M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States

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