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

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Phase 2
Completed
Conditions
First Posted Date
2003-10-07
Last Posted Date
2014-02-20
Lead Sponsor
Children's Oncology Group
Target Recruit Count
350
Registration Number
NCT00070174
Locations
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Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States

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St. Barnabas Medical Center, Livingston, New Jersey, United States

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All Children's Hospital, St. Petersburg, Florida, United States

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First Posted Date
2003-10-07
Last Posted Date
2018-06-12
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
121
Registration Number
NCT00070135
Locations
🇺🇸

New York Weill Cornell Cancer Center at Cornell University, New York, New York, United States

🇺🇸

Mount Sinai Medical Center, New York, New York, United States

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Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

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First Posted Date
2003-09-11
Last Posted Date
2018-02-07
Lead Sponsor
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Target Recruit Count
60
Registration Number
NCT00068250
Locations
🇺🇸

Providence Milwaukie Hospital, Milwaukie, Oregon, United States

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Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States

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Flagler Cancer Center, Saint Augustine, Florida, United States

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506U78 in Treating Patients With Refractory Hematologic Cancer

First Posted Date
2003-08-11
Last Posted Date
2013-07-02
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
148
Registration Number
NCT00002970
Locations
🇺🇸

Children's Oncology Group, Arcadia, California, United States

Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer

Phase 3
Completed
Conditions
First Posted Date
2003-07-08
Last Posted Date
2013-08-02
Lead Sponsor
Institute of Cancer Research, United Kingdom
Target Recruit Count
6000
Registration Number
NCT00002582
Locations
🇬🇧

Cancer Research Campaign Trials Unit-Birmingham (CRCTU), Birmingham, England, United Kingdom

🇬🇧

Beatson Oncology Centre, Glasgow, Scotland, United Kingdom

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Phase 2
Completed
Conditions
First Posted Date
2003-06-20
Last Posted Date
2010-05-13
Lead Sponsor
Fred Hutchinson Cancer Center
Registration Number
NCT00025545
Locations
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Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

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Phase 2
Completed
Conditions
First Posted Date
2003-06-12
Last Posted Date
2012-02-20
Lead Sponsor
National Institutes of Health Clinical Center (CC)
Registration Number
NCT00018954
Locations
🇺🇸

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States

🇪🇬

National Cancer Institute of Egypt, Cairo, Egypt

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Kidwai Memorial Institute of Oncology, Bangalore, India

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First Posted Date
2003-05-21
Last Posted Date
2013-08-21
Lead Sponsor
Children's Oncology Group
Target Recruit Count
83
Registration Number
NCT00005977
Locations
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Emory University Hospital - Atlanta, Atlanta, Georgia, United States

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St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States

🇺🇸

Texas Oncology P.A., Dallas, Texas, United States

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