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

COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2005-08-22
Last Posted Date
2013-12-11
Lead Sponsor
University of Western Ontario, Canada
Target Recruit Count
128
Registration Number
NCT00132899
Locations
🇨🇦

Robarts Clinical Trials, Robarts Research Institute, London, Ontario, Canada

Applying Pediatric Regimens to Younger Adult Patients With Acute Lymphoblastic Leukemia (ALL)

First Posted Date
2005-08-17
Last Posted Date
2008-11-14
Lead Sponsor
Japan Adult Leukemia Study Group
Target Recruit Count
120
Registration Number
NCT00131053
Locations
🇯🇵

Department of Hematology, Nagoya University Graduate School of Medicine, Nagoya, Japan

High-Dose Methotrexate (MTX) for Adult Acute Lymphoblastic Leukemia (ALL)

First Posted Date
2005-08-17
Last Posted Date
2008-11-14
Lead Sponsor
Japan Adult Leukemia Study Group
Target Recruit Count
240
Registration Number
NCT00131027
Locations
🇯🇵

Department of Hematology, Nagoya University Graduate School of Medicine, Nagoya, Japan

Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)

First Posted Date
2005-08-15
Last Posted Date
2008-11-14
Lead Sponsor
Japan Adult Leukemia Study Group
Target Recruit Count
100
Registration Number
NCT00130195
Locations
🇯🇵

Department of Hematology, Nagoya University Graduate School of Medicine, Nagoya, Japan

Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma

First Posted Date
2005-08-03
Last Posted Date
2013-05-23
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
10
Registration Number
NCT00126191
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

A Study of Cyclophosphamide/Methotrexate/5-Fluorouracil (CMF) With Pegfilgrastim in Subjects With Breast Cancer

Phase 2
Completed
Conditions
First Posted Date
2005-07-27
Last Posted Date
2010-02-26
Lead Sponsor
Amgen
Registration Number
NCT00124111

Remission and Joint Damage Progression in Early Rheumatoid Arthritis

First Posted Date
2005-07-22
Last Posted Date
2010-11-16
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
1052
Registration Number
NCT00122382
Locations
🇬🇧

Local Institution, Newcastle, Northumberland, United Kingdom

🇺🇸

Lion Research, Norman, Oklahoma, United States

🇺🇸

Diagnostic Rheumatology And Research, Indianapolis, Indiana, United States

and more 17 locations

S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma

First Posted Date
2005-07-21
Last Posted Date
2012-04-03
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
1
Registration Number
NCT00121186
Locations
🇺🇸

Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States

🇺🇸

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States

🇺🇸

Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States

and more 30 locations

Bevacizumab With or Without Cyclophosphamide and Methotrexate: A Pilot Study in Women With Operable Breast Cancer

First Posted Date
2005-07-21
Last Posted Date
2013-12-24
Lead Sponsor
Harold J. Burstein, MD, PhD
Target Recruit Count
164
Registration Number
NCT00121134
Locations
🇺🇸

Indiana University Cancer Center, Indianapolis, Indiana, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 2 locations

Methotrexate, Trimetrexate Glucuronate, and Leucovorin in Treating Patients With Refractory or Recurrent Osteosarcoma

Phase 1
Completed
Conditions
First Posted Date
2005-07-13
Last Posted Date
2013-01-17
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
18
Registration Number
NCT00119301
Locations
🇺🇸

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

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