MedPath

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

Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer

Phase 2
Completed
Conditions
Kidney Cancer
Interventions
Biological: filgrastim
Biological: therapeutic allogeneic lymphocytes
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: methotrexate
Drug: tacrolimus
Procedure: peripheral blood stem cell transplantation
First Posted Date
2003-01-27
Last Posted Date
2016-07-14
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
36
Registration Number
NCT00027573
Locations
🇺🇸

CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, United States

🇺🇸

CCOP - Oklahoma, Tulsa, Oklahoma, United States

🇺🇸

Indiana University Cancer Center, Indianapolis, Indiana, United States

and more 3 locations

Combination Chemotherapy and Peripheral Stem Cell Transplant in Treating Patients With Relapsed Hodgkin's Lymphoma

Phase 3
Conditions
Lymphoma
First Posted Date
2003-01-27
Last Posted Date
2013-09-17
Lead Sponsor
German Hodgkin's Lymphoma Study Group
Target Recruit Count
220
Registration Number
NCT00025636
Locations
🇧🇪

Ziekenhuis Netwerk Antwerpen Middelheim, Antwerp, Belgium

🇩🇪

Universitaetsklinikum Essen, Essen, Germany

🇩🇪

Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet, Greifswald, Germany

and more 41 locations

Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

Phase 2
Completed
Conditions
Lymphoma
Interventions
First Posted Date
2003-01-27
Last Posted Date
2016-07-19
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
79
Registration Number
NCT00020943
Locations
🇺🇸

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

🇺🇸

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States

and more 78 locations

Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma

First Posted Date
2003-01-27
Last Posted Date
2019-08-06
Lead Sponsor
Children's Oncology Group
Target Recruit Count
393
Registration Number
NCT00004228
Locations
🇺🇸

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States

🇺🇸

Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, United States

🇺🇸

MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia, United States

and more 172 locations

Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia

First Posted Date
2003-01-27
Last Posted Date
2016-02-23
Lead Sponsor
Children's Oncology Group
Target Recruit Count
3054
Registration Number
NCT00005945
Locations
🇺🇸

Medical City Dallas Hospital, Dallas, Texas, United States

🇺🇸

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland, Ohio, United States

🇺🇸

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

and more 127 locations

Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor

Phase 2
Withdrawn
Conditions
Retinoblastoma
Brain and Central Nervous System Tumors
Neuroblastoma
Sarcoma
First Posted Date
2003-01-27
Last Posted Date
2015-12-03
Lead Sponsor
NYU Langone Health
Registration Number
NCT00003273
Locations
🇺🇸

Cancer Research Center of Hawaii, Honolulu, Hawaii, United States

🇺🇸

State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States

🇺🇸

Maine Children's Cancer Program, Scarborough, Maine, United States

and more 16 locations

Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

Phase 2
Completed
Conditions
Multiple Myeloma
Plasma Cell Neoplasm
Interventions
First Posted Date
2003-01-27
Last Posted Date
2016-07-04
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
60
Registration Number
NCT00028600
Locations
🇺🇸

Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States

🇺🇸

Union Hospital Cancer Program at Union Hospital, Elkton MD, Maryland, United States

🇺🇸

CCOP - Christiana Care Health Services, Newark, Delaware, United States

and more 12 locations

Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission

Phase 3
Completed
Conditions
Leukemia
Interventions
Biological: sargramostim
Drug: cyclophosphamide
Drug: asparaginase
Drug: cytarabine
Drug: dexamethasone
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: imatinib mesylate
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Procedure: allogeneic bone marrow transplantation
Radiation: radiation therapy
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
First Posted Date
2003-01-27
Last Posted Date
2023-06-18
Lead Sponsor
Eastern Cooperative Oncology Group
Target Recruit Count
1929
Registration Number
NCT00002514
Locations
🇺🇸

Drexel University College of Medicine - Center City Hahnemann Campus, Philadelphia, Pennsylvania, United States

🇺🇸

MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States

🇺🇸

Swedish Medical Center, Englewood, Colorado, United States

and more 91 locations

Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia

First Posted Date
2003-01-27
Last Posted Date
2023-08-21
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
105
Registration Number
NCT00039130
Locations
🇺🇸

University of Illinois Cancer Center, Chicago, Illinois, United States

🇺🇸

University of Chicago Cancer Research Center, Chicago, Illinois, United States

🇺🇸

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

and more 28 locations

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

Phase 2
Completed
Conditions
Lymphoma
Graft Versus Host Disease
Interventions
First Posted Date
2003-01-27
Last Posted Date
2016-07-19
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
4
Registration Number
NCT00006747
Locations
🇺🇸

University of Chicago Cancer Research Center, Chicago, Illinois, United States

🇺🇸

University of Massachusetts Memorial Medical Center - University Campus, Worcester, Massachusetts, United States

🇺🇸

University of Illinois at Chicago, Chicago, Illinois, United States

and more 45 locations
© Copyright 2025. All Rights Reserved by MedPath