Methotrexate

Generic Name: Methotrexate

Brand Names: Metoject, Nordimet, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep, Jylamvo

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₂N_₈O_₅

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

Clinical Trials

A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)

Phase 3

Terminated

Conditions: Rheumatoid Arthritis

Interventions: Drug: Methotrexate
Drug: Placebo
Drug: ocrelizumab

First Posted Date: 2006-12-04

Last Posted Date: 2020-11-27

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 1015

Registration Number: NCT00406419

Locations: 🇺🇸
Trial Information Support Line, South San Francisco, California, United States

Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy

Not Applicable

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Etanercept
Drug: methotrexate
Drug: Sulfasalazine
Drug: Placebo, triple
Drug: Hydroxychloroquine
Drug: Placebo, etanercept

First Posted Date: 2006-11-30

Last Posted Date: 2013-12-03

Lead Sponsor: US Department of Veterans Affairs

Target Recruit Count: 353

Registration Number: NCT00405275

Locations: 🇺🇸
VA Medical Center, Loma Linda, Loma Linda, California, United States
🇺🇸
VA Pittsburgh Health Care System, Pittsburgh, Pennsylvania, United States
🇺🇸
Geisinger Medical Group - State College, State College, Pennsylvania, United States

and more 34 locations

Alloreactive NK Cells for Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Phase 1

Completed

Conditions: Leukemia
Myelodysplastic Syndrome

Interventions: Drug: Thymoglobulin
Drug: Busulfan
Drug: Fludarabine
Procedure: Alloreactive NK Infusion
Drug: G-CSF
Drug: Tacrolimus
Drug: Methotrexate
Drug: Interleukin-2

First Posted Date: 2006-11-22

Last Posted Date: 2015-05-08

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 15

Registration Number: NCT00402558

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

Treatment of Acute Lymphoblastic Leukemia in Children

Phase 3

Completed

Conditions: Drug/Agent Toxicity by Tissue/Organ
Leukemia

Interventions: Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexrazoxane hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: etoposide
Drug: mercaptopurine
Drug: methotrexate
Drug: pegaspargase
Drug: methylprednisolone
Drug: prednisolone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Radiation: radiation therapy

First Posted Date: 2006-11-17

Last Posted Date: 2024-11-27

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 800

Registration Number: NCT00400946

Locations: 🇨🇦
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada
🇺🇸
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States
🇨🇦
Centre de Recherche du Centre Hospitalier de l'Universite Laval, Sainte Foy, Quebec, Canada

and more 5 locations

BBBD Followed By Methotrexate and Carboplatin With or Without Trastuzumab in Treating Women With Breast Cancer That Has Spread to the Brain

Phase 1

Withdrawn

Conditions: Drug/Agent Toxicity by Tissue/Organ
Cognitive/Functional Effects
Brain and Central Nervous System Tumors
Breast Cancer
Psychosocial Effects of Cancer and Its Treatment

Interventions: Drug: carboplatin
Biological: trastuzumab
Drug: methotrexate
Drug: sodium thiosulfate

First Posted Date: 2006-11-09

Last Posted Date: 2017-04-21

Lead Sponsor: OHSU Knight Cancer Institute

Registration Number: NCT00397501

A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study

Phase 4

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Infliximab, methylprednisolone, methotrexate
Drug: Methotrexate + Methylprednisolone
Drug: Methotrexate + Infliximab
Drug: Methotrexate

First Posted Date: 2006-11-07

Last Posted Date: 2007-10-19

Lead Sponsor: Université Catholique de Louvain

Target Recruit Count: 45

Registration Number: NCT00396747

Locations: 🇧🇪
Université catholique de Louvain, Brussels, Belgium

Combination Chemotherapy With or Without Etoposide Followed By an Autologous Stem Cell Transplant in Treating Young Patients With Previously Untreated Malignant Brain Tumors

Phase 3

Conditions: Brain and Central Nervous System Tumors

Interventions: Drug: carboplatin
Drug: temozolomide
Drug: cisplatin
Drug: thiotepa
Drug: cyclophosphamide
Drug: vincristine sulfate
Drug: etoposide
Procedure: autologous bone marrow transplantation
Drug: methotrexate
Procedure: autologous hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy

First Posted Date: 2006-10-26

Last Posted Date: 2013-12-18

Lead Sponsor: Children's Hospital Los Angeles

Target Recruit Count: 120

Registration Number: NCT00392886

Locations: 🇺🇸
Childrens Hospital Los Angeles, Los Angeles, California, United States
🇦🇺
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
🇺🇸
Children's Hospital of Orange County, Orange, California, United States

and more 34 locations

Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma

Phase 2

Completed

Conditions: Lymphoma

Interventions: Biological: filgrastim
Biological: pegfilgrastim
Biological: rituximab
Drug: cyclophosphamide
Drug: cytarabine
Drug: etoposide
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Drug: liposomal cytarabine
Drug: leucovorin calcium
Drug: methotrexate
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate

First Posted Date: 2006-10-26

Last Posted Date: 2018-06-06

Lead Sponsor: AIDS Malignancy Consortium

Target Recruit Count: 34

Registration Number: NCT00392834

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
🇺🇸
UCLA Clinical AIDS Research and Education (CARE) Center, Los Angeles, California, United States
🇺🇸
Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center, Seattle, Washington, United States

and more 10 locations

Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.

Phase 2

Completed

Conditions: BCR-ABL1 Fusion Protein Expression
Recurrent Acute Lymphoblastic Leukemia
t(9;22)
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Philadelphia Chromosome Positive
Acute Lymphoblastic Leukemia