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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

Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery

Phase 2
Completed
Conditions
Estrogen Receptor-negative Breast Cancer
Estrogen Receptor-positive Breast Cancer
Progesterone Receptor-negative Breast Cancer
Progesterone Receptor-positive Breast Cancer
Stage IA Breast Cancer
Stage IB Breast Cancer
HER2-positive Breast Cancer
Stage IIIA Breast Cancer
Stage II Breast Cancer
Interventions
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: paclitaxel
Biological: filgrastim
Drug: capecitabine
Drug: methotrexate
Drug: vinorelbine tartrate
Procedure: needle biopsy
Procedure: therapeutic conventional surgery
Other: immunohistochemistry staining method
Biological: trastuzumab
Drug: tamoxifen citrate
Drug: letrozole
Other: laboratory biomarker analysis
First Posted Date
2005-09-19
Last Posted Date
2018-03-12
Lead Sponsor
University of Washington
Target Recruit Count
50
Registration Number
NCT00194779
Locations
🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Trial to Evaluate Palifermin in the Reduction of Acute Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Allogeneic Marrow/Peripheral Blood Progenitor Cell (PBPC) Transplantation

Phase 2
Completed
Conditions
Graft Versus Host Disease
Hematologic Malignancies
Interventions
Drug: Placebo
Drug: Palifermin
Other: Conditioning Regimen
Procedure: Allogeneic stem cell transplant
Drug: Methotrexate
First Posted Date
2005-09-19
Last Posted Date
2014-09-15
Lead Sponsor
Swedish Orphan Biovitrum
Target Recruit Count
155
Registration Number
NCT00189488

Treatment for Patients With Stage III or IV Non-Hodgkin Lymphoma

First Posted Date
2005-09-16
Last Posted Date
2008-04-23
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
42
Registration Number
NCT00187122
Locations
🇺🇸

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

CINJALL: Treatment for Children With Acute Lymphocytic Leukemia

First Posted Date
2005-09-15
Last Posted Date
2014-06-09
Lead Sponsor
Rutgers, The State University of New Jersey
Target Recruit Count
60
Registration Number
NCT00176462
Locations
🇺🇸

Jersey Shore University Medical Center, Neptune, New Jersey, United States

🇺🇸

Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Treatment of Acute Lymphoblastic Leukemia in Children

First Posted Date
2005-09-14
Last Posted Date
2013-04-25
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
498
Registration Number
NCT00165178
Locations
🇺🇸

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

Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

Phase 4
Completed
Conditions
Psoriasis
Arthritis, Psoriatic
First Posted Date
2005-09-12
Last Posted Date
2009-09-28
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
60
Registration Number
NCT00161655

A Study of Imatinib 400 mg Once Daily in Combination With Methotrexate in the Treatment of Rheumatoid Arthritis.

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2005-09-12
Last Posted Date
2017-04-25
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
50
Registration Number
NCT00154336
Locations
🇬🇧

Novartis Investigative site, Stoke-on-Trent, United Kingdom

🇬🇧

Multiple Sites, Multiple Cities, United Kingdom

Whole Brain Irradiation in Primary Central Nervous System (CNS) Lymphoma (PCNSL)

Phase 4
Completed
Conditions
Central Nervous System Lymphoma
Interventions
Drug: methotrexate
Radiation: radiotherapy
First Posted Date
2005-09-12
Last Posted Date
2009-12-24
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
604
Registration Number
NCT00153530
Locations
🇩🇪

Charite Campus Benjamin Franklin, Berlin, Germany

Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation

Phase 2
Completed
Conditions
Graft Versus Host Disease
Hematologic Malignancies
First Posted Date
2005-09-07
Last Posted Date
2012-03-08
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
105
Registration Number
NCT00146614
Locations
🇺🇸

Beth Isreal Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

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

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: MRA(Tocilizumab)
Drug: MRA placebo
Drug: MTX placebo
Drug: MTX
First Posted Date
2005-09-05
Last Posted Date
2009-02-02
Lead Sponsor
Chugai Pharmaceutical
Target Recruit Count
127
Registration Number
NCT00144521
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