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

Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia

Phase 3
Completed
Conditions
First Posted Date
2003-01-27
Last Posted Date
2014-02-20
Lead Sponsor
Children's Oncology Group
Target Recruit Count
276
Registration Number
NCT00005603
Locations
🇺🇸

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

🇺🇸

Children's Hospital Los Angeles, Los Angeles, California, United States

🇺🇸

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

and more 17 locations

Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes

First Posted Date
2003-01-27
Last Posted Date
2023-06-28
Lead Sponsor
Eastern Cooperative Oncology Group
Target Recruit Count
17
Registration Number
NCT00045305
Locations
🇺🇸

Jewish Hospital Cancer Center, Cincinnati, Ohio, United States

🇺🇸

Mayo Clinic - Jacksonville, Jacksonville, Florida, United States

🇺🇸

Mayo Clinic Scottsdale, Scottsdale, Arizona, United States

and more 3 locations

Induction Intensification in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia

First Posted Date
2003-01-27
Last Posted Date
2014-02-14
Lead Sponsor
Children's Oncology Group
Target Recruit Count
221
Registration Number
NCT00002756
Locations
🇺🇸

Children's Hospital Central California, Madera, California, United States

🇺🇸

Winship Cancer Institute of Emory University, Atlanta, Georgia, United States

🇺🇸

Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida, United States

and more 137 locations

Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Advanced Hematologic Cancer

First Posted Date
2003-01-27
Last Posted Date
2013-03-07
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Registration Number
NCT00014469
Locations
🇺🇸

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

Combination Chemotherapy in Treating Children With Anaplastic Large Cell Lymphoma (ALCL 99)

Phase 3
Completed
Conditions
First Posted Date
2003-01-27
Last Posted Date
2022-05-31
Lead Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Target Recruit Count
885
Registration Number
NCT00006455
Locations
🇫🇷

Institut Gustave Roussy, Villejuif, France

🇦🇹

St. Anna Children's Hospital, Vienna, Austria

🇩🇪

Kinderklinik, Giessen, Germany

and more 7 locations

Combination Chemotherapy Followed by Radiation Therapy in Treating Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Ependymoma

Phase 2
Completed
Conditions
First Posted Date
2003-01-27
Last Posted Date
2013-07-18
Lead Sponsor
Children's Hospital Los Angeles
Registration Number
NCT00006258
Locations
🇺🇸

Geisinger Medical Center, Danville, Pennsylvania, United States

🇺🇸

Children's Hospital Los Angeles, Los Angeles, California, United States

🇨🇦

Tom Baker Cancer Centre - Calgary, Calgary, Alberta, Canada

Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer

First Posted Date
2003-01-27
Last Posted Date
2013-07-10
Lead Sponsor
Burzynski Research Institute
Registration Number
NCT00003536
Locations
🇺🇸

Burzynski Clinic, Houston, Texas, United States

Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome

First Posted Date
2003-01-27
Last Posted Date
2013-06-27
Lead Sponsor
Children's Oncology Group
Target Recruit Count
254
Registration Number
NCT00003593
Locations
🇺🇸

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States

🇺🇸

Naval Medical Center, Portsmouth, Portsmouth, Virginia, United States

🇺🇸

Children's Memorial Hospital - Chicago, Chicago, Illinois, United States

and more 233 locations

Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium

First Posted Date
2003-01-27
Last Posted Date
2013-06-12
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
238
Registration Number
NCT00014274
Locations
🇳🇱

Academisch Medisch Centrum at University of Amsterdam, Amsterdam, Netherlands

🇧🇪

Institut Jules Bordet, Brussels, Belgium

🇳🇱

Universitair Medisch Centrum St. Radboud - Nijmegen, Nijmegen, Netherlands

and more 26 locations

Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia

Phase 3
Completed
Conditions
First Posted Date
2003-01-27
Last Posted Date
2013-06-12
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
392
Registration Number
NCT00002700
Locations
🇸🇰

Institute of Hematology & Transfusiology, University Hospital, Bratislava, Slovakia

🇧🇪

Hopital Universitaire Erasme, Brussels, Belgium

🇧🇪

Universitair Ziekenhuis Antwerpen, Edegem, Belgium

and more 41 locations
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