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

Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

Phase 3
Completed
Conditions
Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia
Childhood B Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2008-05-02
Last Posted Date
2021-04-27
Lead Sponsor
Children's Oncology Group
Target Recruit Count
166
Registration Number
NCT00671034
Locations
🇺🇸

Connecticut Children's Medical Center, Hartford, Connecticut, United States

🇺🇸

University of Connecticut, Farmington, Connecticut, United States

🇺🇸

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

and more 24 locations

Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ AML/MDS/JMML

Phase 1
Terminated
Conditions
Acute Myeloid Leukemia
Juvenile Myelomonocytic Leukemia
Myelodysplastic Syndrome
Interventions
First Posted Date
2008-05-01
Last Posted Date
2015-04-22
Lead Sponsor
New York Medical College
Target Recruit Count
12
Registration Number
NCT00669890
Locations
🇺🇸

Morgan Stanley Children's Hospital of NYP, New York City, New York, United States

High-Dose Chemotherapy Given Together With Peripheral Blood Stem Cell Transplant in Treating Patients With Intestinal T-Cell Lymphoma

Phase 2
Conditions
Lymphoma
Small Intestine Cancer
First Posted Date
2008-05-01
Last Posted Date
2013-08-26
Lead Sponsor
Cancer Research UK
Target Recruit Count
60
Registration Number
NCT00669812
Locations
🇬🇧

Sir James Spence Institute of Child Health at Royal Victoria Infirmary, Newcastle-Upon-Tyne, England, United Kingdom

Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma

First Posted Date
2008-05-01
Last Posted Date
2018-05-16
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
56
Registration Number
NCT00669877
Locations
🇺🇸

The University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States

A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma

Phase 2
Completed
Conditions
Malignant Fibrous Histiocytoma (MFH) of Bone
Osteosarcoma
Interventions
Biological: Bevacizumab
Drug: Cisplatin
Drug: Doxorubicin
Drug: Methotrexate
Procedure: Surgery
Drug: Ifosfamide
Drug: etoposide
Radiation: Radiotherapy
First Posted Date
2008-04-28
Last Posted Date
2023-08-07
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
43
Registration Number
NCT00667342
Locations
🇺🇸

Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

🇺🇸

NCI/NIH - Pediatric Oncology Branch, Bethesda, Maryland, United States

and more 2 locations

Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis

Phase 2
Conditions
Fingernail Psoriasis
Interventions
First Posted Date
2008-04-24
Last Posted Date
2009-02-10
Lead Sponsor
MediQuest Therapeutics
Target Recruit Count
83
Registration Number
NCT00666354
Locations
🇬🇧

University of Manchester, The Dermatology Centre, Salford, Manchester, United Kingdom

🇬🇧

University Hospital of Wales, Welsh Institute of Dermatology, Cardiff, United Kingdom

🇬🇧

Aberdeen Royal Infirmary Dermatology Outpatients Clinic, Aberdeen, United Kingdom

and more 4 locations

A Placebo-controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic Arthritis

Phase 2
Completed
Conditions
Psoriatic Arthritis
Interventions
First Posted Date
2008-04-16
Last Posted Date
2014-09-18
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
185
Registration Number
NCT00659412

Community-Based Interventions for Infant Health in Nepal

Conditions
Child Mortality
First Posted Date
2008-04-11
Last Posted Date
2008-04-11
Lead Sponsor
Institute of Child Health
Target Recruit Count
192000
Registration Number
NCT00656591
Locations
🇬🇧

International Child Health, ICH, London, United Kingdom

CAMEO: Canadian Methotrexate and Etanercept Outcome Study

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
Biological: Etanercept
Drug: Methotrexate
First Posted Date
2008-04-08
Last Posted Date
2014-07-23
Lead Sponsor
Amgen
Target Recruit Count
258
Registration Number
NCT00654368
Locations
🇨🇦

Research Site, Quebec, Canada

Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System

Phase 3
Completed
Conditions
Childhood Atypical Teratoid/Rhabdoid Tumor
Interventions
Radiation: 3-Dimensional Conformal Radiation Therapy
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Etoposide
Biological: Filgrastim
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Methotrexate
Drug: Thiotepa
Drug: Vincristine Sulfate
First Posted Date
2008-04-04
Last Posted Date
2024-04-23
Lead Sponsor
Children's Oncology Group
Target Recruit Count
70
Registration Number
NCT00653068
Locations
🇺🇸

Prisma Health Richland Hospital, Columbia, South Carolina, United States

🇺🇸

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States

🇺🇸

Lee Memorial Health System, Fort Myers, Florida, United States

and more 91 locations
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