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

Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia

Phase 1
Recruiting
Conditions
High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
Recurrent Burkitt Lymphoma
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
Burkitt-Like Lymphoma With 11q Aberration
Recurrent B Acute Lymphoblastic Leukemia
High Grade B-Cell Lymphoma, Not Otherwise Specified
Refractory B Acute Lymphoblastic Leukemia
Refractory Burkitt Lymphoma
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Interventions
Biological: Blinatumomab
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Biological: Inotuzumab Ozogamicin
Drug: Methotrexate
Other: Laboratory Biomarker Analysis
Drug: Mercaptopurine
Drug: Prednisone
Biological: Rituximab
Drug: Vincristine
First Posted Date
2011-06-13
Last Posted Date
2024-07-05
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
276
Registration Number
NCT01371630
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Phase 2
Completed
Conditions
Adult Acute Lymphoblastic Leukemia in Complete Remission
Burkitt Leukemia
Burkitt Lymphoma
Childhood Acute Lymphoblastic Leukemia in Complete Remission
Acute Lymphoblastic Leukemia
CD20 Positive
Lymphoblastic Lymphoma
Interventions
First Posted Date
2011-06-01
Last Posted Date
2021-05-03
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
72
Registration Number
NCT01363128
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia

First Posted Date
2011-05-23
Last Posted Date
2014-05-20
Lead Sponsor
Ruijin Hospital
Target Recruit Count
100
Registration Number
NCT01358253
Locations
🇨🇳

Ruijin Hospital, Shanghai, Shanghai, China

PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years

Phase 4
Conditions
Acute Lymphoblastic Leukemia
First Posted Date
2011-05-23
Last Posted Date
2022-01-19
Lead Sponsor
PETHEMA Foundation
Target Recruit Count
100
Registration Number
NCT01358201
Locations
🇪🇸

Hospital de Alcorcón, Alcorcón, Spain

🇪🇸

Hospital Germans Trias i Pujol, Badalona, Spain

🇪🇸

Fundación Hospital Alcorcón, Alcorcón, Spain

and more 70 locations

A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2011-05-16
Last Posted Date
2014-06-06
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
39
Registration Number
NCT01353859

LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

Phase 3
Completed
Conditions
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Interventions
First Posted Date
2011-05-02
Last Posted Date
2018-02-15
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
483
Registration Number
NCT01345682
Locations
🇯🇵

1200.43.08111 Boehringer Ingelheim Investigational Site, Hyogo, Akashi, Japan

🇯🇵

1200.43.08107 Boehringer Ingelheim Investigational Site, Hyogo, Kobe, Japan

🇫🇷

1200.43.03303 Boehringer Ingelheim Investigational Site, Lille Cedex, France

and more 98 locations

Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation

Phase 2
Completed
Conditions
Myelodysplastic Syndrome
Acute Lymphocytic Leukemia
Acute Myelogenous Leukemia
Chronic Myelogenous Leukemia
Chronic Myelomonocytic Leukemia
Interventions
Procedure: First Allogeneic Bone Marrow Transplant (BMT)
Drug: Leuprolide
Drug: 18F FLT
Drug: Cyclophosphamide
Drug: Methotrexate
Drug: Busulfan
Drug: Tacrolimus
Drug: Fludarabine
Radiation: Total Body Irradiation
Procedure: Second Allogeneic Bone Marrow Transplantation
First Posted Date
2011-04-20
Last Posted Date
2021-03-18
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
76
Registration Number
NCT01338987
Locations
🇺🇸

Childrens National Medical Center, Washington, District of Columbia, United States

🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

🇺🇸

University of Oklahoma, Oklahoma City, Oklahoma, United States

Bortezomib-based GVHD Prophylaxis After Allogeneic Transplant for Patients Without Matched Related Donors

Phase 2
Completed
Conditions
Leukemia
Myelodysplastic Syndrome
Lymphoma
Interventions
First Posted Date
2011-03-28
Last Posted Date
2017-05-30
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
35
Registration Number
NCT01323920
Locations
🇺🇸

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

Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia

First Posted Date
2011-03-22
Last Posted Date
2022-09-27
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
31
Registration Number
NCT01319981
Locations
🇺🇸

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

Treatment of Non-infectious Intermediate and Posterior Uveitis Associated Macular Edema With Intravitreal Methotrexate

Phase 1
Terminated
Conditions
Non-infectious Intermediate and Posterior Uveitis
Interventions
First Posted Date
2011-03-14
Last Posted Date
2019-03-27
Lead Sponsor
National Eye Institute (NEI)
Target Recruit Count
2
Registration Number
NCT01314417
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

© Copyright 2025. All Rights Reserved by MedPath