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

S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia

Phase 3
Completed
Conditions
Leukemia
Interventions
First Posted Date
2007-06-27
Last Posted Date
2023-01-10
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
105
Registration Number
NCT00492856
Locations
🇺🇸

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

🇺🇸

Illinois CancerCare - Havana, Havana, Illinois, United States

🇺🇸

Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States

and more 206 locations

Beclomethasone Dipropionate in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

Phase 2
Completed
Conditions
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Hematopoietic/Lymphoid Cancer
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Childhood Acute Myeloid Leukemia in Remission
Chronic Eosinophilic Leukemia
Chronic Phase Chronic Myelogenous Leukemia
Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Contiguous Stage II Grade 3 Follicular Lymphoma
Interventions
Drug: placebo
Drug: beclomethasone dipropionate
Drug: tacrolimus
Drug: methotrexate
Procedure: allogeneic hematopoietic stem cell transplantation
First Posted Date
2007-06-21
Last Posted Date
2021-02-03
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
140
Registration Number
NCT00489203
Locations
🇺🇸

Hackensack University Medical Center, Hackensack, New Jersey, United States

🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)

Phase 3
Terminated
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2007-06-13
Last Posted Date
2020-11-03
Lead Sponsor
Genentech, Inc.
Target Recruit Count
613
Registration Number
NCT00485589

Phase III Trial in Acute Promyelocytic Leukemia Patients

Phase 3
Completed
Conditions
Leukemia
Interventions
First Posted Date
2007-06-05
Last Posted Date
2022-10-12
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Target Recruit Count
276
Registration Number
NCT00482833
Locations
🇦🇹

Universitätsklinik Innsbruck Hämatologie Onkologie, Innsbruck, Austria

🇦🇹

Krankenhaus der Barmherzigen Schwestern Linz, Linz, Austria

🇦🇹

Universitätsklinik für Innere Medizin III Salzburg, Salzburg, Austria

and more 106 locations

Bortezomib, Rituximab and Combination Chemotherapy in Treating Participants With Mantle Cell Lymphoma

First Posted Date
2007-05-23
Last Posted Date
2022-01-28
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
107
Registration Number
NCT00477412
Locations
🇺🇸

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

A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)

Phase 3
Terminated
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2007-05-22
Last Posted Date
2019-08-12
Lead Sponsor
Genentech, Inc.
Target Recruit Count
836
Registration Number
NCT00476996
Locations
🇺🇸

Pinnacle Research Group; Llc, Central, Anniston, Alabama, United States

🇺🇸

Center For Arthritis & Osteoporosis, Elizabethtown, Kentucky, United States

🇺🇸

Arthritis Consultants, Saint Louis, Missouri, United States

and more 261 locations

ALL Adult Consortium Trial: Adult ALL Trial

First Posted Date
2007-05-21
Last Posted Date
2024-04-17
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
112
Registration Number
NCT00476190
Locations
🇺🇸

Ohio State University Medical Center, Columbus, Ohio, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Children's Hospital of Boston, Boston, Massachusetts, United States

and more 12 locations

Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma

Phase 3
Active, not recruiting
Conditions
Sarcoma
Interventions
First Posted Date
2007-05-07
Last Posted Date
2024-04-18
Lead Sponsor
UNICANCER
Target Recruit Count
318
Registration Number
NCT00470223
Locations
🇫🇷

Centre Jean Perrin, Clermont-Ferrand, France

🇫🇷

CHR de Besancon - Hopital Saint-Jacques, Besancon, France

🇫🇷

CHU Hopital A. Morvan, Brest, France

and more 34 locations

A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: MabThera/Rituxan
Drug: Methotrexate
Other: Placebo
First Posted Date
2007-05-02
Last Posted Date
2016-10-25
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
520
Registration Number
NCT00468546

Pharmacologic Study of Methotrexate in Patients Undergoing Stereotactic Biopsy for Recurrent High-Grade Glioma

Not Applicable
Completed
Conditions
Brain and Central Nervous System Tumors
First Posted Date
2007-04-19
Last Posted Date
2013-06-24
Lead Sponsor
New Approaches to Brain Tumor Therapy Consortium
Target Recruit Count
12
Registration Number
NCT00463008
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