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

Sunitinib, Cyclophosphamide, and Methotrexate in Treating Patients With Metastatic Breast Cancer

Phase 1
Terminated
Conditions
Breast Cancer
Interventions
First Posted Date
2008-02-15
Last Posted Date
2020-01-13
Lead Sponsor
University of California, San Francisco
Target Recruit Count
32
Registration Number
NCT00616122
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

Sirolimus, Tacrolimus and Short Course Methotrexate for Prevention of Acute GVHD in Recipients of Mismatched Unrelated Donor Allogeneic Stem Cell Transplantation

Early Phase 1
Completed
Conditions
Stem Cell Transplantation
Interventions
First Posted Date
2008-02-11
Last Posted Date
2016-11-30
Lead Sponsor
Yale University
Target Recruit Count
26
Registration Number
NCT00612274
Locations
🇺🇸

Yale University School of Medicine, New Haven, Connecticut, United States

Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation

Phase 1
Terminated
Conditions
Leukemia
Interventions
Drug: cyclosporine
Drug: cytarabine
Drug: filgrastim
Drug: methotrexate
Drug: methylprednisolone
Drug: mitoxantrone hydrochloride
Procedure: allogeneic bone marrow transplantation
Procedure: umbilical cord blood transplantation
Drug: Cis-Retinoic acid
First Posted Date
2008-02-07
Last Posted Date
2017-12-28
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Target Recruit Count
1
Registration Number
NCT00609739
Locations
🇺🇸

Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States

Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer

Phase 2
Completed
Conditions
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Infection
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Precancerous Condition
Secondary Myelofibrosis
Interventions
Biological: anti-thymocyte globulin
Drug: fludarabine phosphate
Drug: cyclophosphamide
Drug: etoposide
Drug: melphalan
Drug: sirolimus
Drug: methotrexate
Drug: tacrolimus
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: hematopoietic stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: total-body irradiation
First Posted Date
2008-01-09
Last Posted Date
2014-09-10
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
32
Registration Number
NCT00589563
Locations
🇺🇸

City of Hope Comprehensive Cancer Center, Duarte, California, United States

🇺🇸

Banner Good Samaritan Medical Center, Phoenix, Arizona, United States

Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)

Phase 2
Completed
Conditions
Hodgkin's Disease
Interventions
First Posted Date
2008-01-08
Last Posted Date
2009-06-12
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
18
Registration Number
NCT00587873
Locations
🇺🇸

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

Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With LCH

Phase 2
Completed
Conditions
Langerhans Cell Histiocytosis
Interventions
First Posted Date
2008-01-08
Last Posted Date
2015-05-04
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
5
Registration Number
NCT00588536
Locations
🇺🇸

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

Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma

Phase 2
Completed
Conditions
Osteosarcoma
Interventions
First Posted Date
2008-01-07
Last Posted Date
2016-01-20
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
40
Registration Number
NCT00586846
Locations
🇺🇸

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

Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Combination of Minocycline and MTX or MTX alone
Drug: methotrexate
First Posted Date
2007-12-24
Last Posted Date
2023-10-06
Lead Sponsor
University of Nebraska
Target Recruit Count
91
Registration Number
NCT00579644
Locations
🇺🇸

Unversity of Nebraska Medical Center, Omaha, Nebraska, United States

Allogeneic Stem Cell Transplant for Patients With Severe Aplastic Anemia

Phase 2
Terminated
Conditions
Aplastic Anemia
Interventions
Drug: Cytoxan
Drug: Campath
Radiation: Total Body Irradiation (TBI)
Drug: FK-506
Drug: Methotrexate
Procedure: Stem cell infusion
First Posted Date
2007-12-21
Last Posted Date
2016-04-22
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
22
Registration Number
NCT00578903
Locations
🇺🇸

The Methodist Hospital, Houston, Texas, United States

🇺🇸

Texas Children's Hospital, Houston, Texas, United States

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