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

Combination Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia

Phase 3

Completed

Conditions: Leukemia

Interventions: Drug: cytarabine
Drug: dexamethasone
Drug: etoposide
Drug: idarubicin
Drug: ifosfamide
Drug: leucovorin calcium
Drug: mesna
Drug: pegaspargase
Drug: therapeutic hydrocortisone
Drug: thioguanine
Drug: vincristine sulfate
Radiation: low-LET electron therapy
Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET photon therapy
Drug: Methotrexate

First Posted Date: 2004-06-23

Last Posted Date: 2013-08-22

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 120

Registration Number: NCT00002816

Locations: 🇺🇸
Children's National Medical Center, Washington, District of Columbia, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸
Kaplan Cancer Center, New York, New York, United States

and more 30 locations

SWOG-9239 Reduction of Immunosuppression Plus Interferon Alfa and Combination Chemotherapy in Treating Patients With Malignant Tumors That Develop After Organ Transplant

Phase 2

Completed

Conditions: Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm

Interventions: Biological: bleomycin sulfate
Biological: recombinant interferon alfa
Drug: cyclophosphamide
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: methotrexate
Drug: prednisone
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: radiation therapy

First Posted Date: 2004-06-22

Last Posted Date: 2013-01-24

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 20

Registration Number: NCT00002657

Locations: 🇺🇸
Providence Hospital - Southfield, Southfield, Michigan, United States
🇺🇸
CCOP - Dayton, Kettering, Ohio, United States
🇺🇸
Boston Medical Center, Boston, Massachusetts, United States

and more 83 locations

Interleukin-2 Gene or Methotrexate in Treating Patients With Recurrent or Refractory Stage III or Stage IV Head and Neck Cancer

Phase 2

Completed

Conditions: Head and Neck Cancer

First Posted Date: 2004-06-21

Last Posted Date: 2013-05-30

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Registration Number: NCT00006033

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Combination Chemotherapy, Bone Marrow Transplantation, and Radiation Therapy in Treating Infants With Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Leukemia

First Posted Date: 2004-06-16

Last Posted Date: 2014-07-24

Lead Sponsor: Children's Oncology Group

Registration Number: NCT00002785

Locations: 🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
🇺🇸
Ireland Cancer Center, Cleveland, Ohio, United States

and more 30 locations

Methotrexate Compared With Paclitaxel in Treating Patients With Advanced Head and Neck Cancer

Phase 3

Completed

Conditions: Head and Neck Cancer

First Posted Date: 2004-06-16

Last Posted Date: 2023-06-22

Lead Sponsor: Eastern Cooperative Oncology Group

Target Recruit Count: 230

Registration Number: NCT00003592

Locations: 🇺🇸
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
🇺🇸
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
🇺🇸
CCOP - Kalamazoo, Kalamazoo, Michigan, United States

and more 17 locations

Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT

Phase 2

Completed

Conditions: Central Nervous System Tumor, Pediatric

Interventions: Biological: filgrastim
Drug: cisplatin
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexrazoxane hydrochloride
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: leucovorin calcium
Drug: methotrexate
Drug: temozolomide
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Radiation: radiation therapy
Drug: Dactinomycin

First Posted Date: 2004-06-11

Last Posted Date: 2015-12-24

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 25

Registration Number: NCT00084838

Locations: 🇺🇸
Stanford Cancer Center, Stanford, California, United States
🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus, Atlanta, Georgia, United States

and more 9 locations

Chemotherapy and Whole-Brain Radiation Therapy in Treating Patients With Primary Central Nervous System Non- Hodgkin's Lymphoma

Phase 2

Completed

Conditions: Lymphoma

Interventions: Drug: carmustine
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: methotrexate
Drug: vincristine sulfate
Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET photon therapy

First Posted Date: 2004-06-10

Last Posted Date: 2016-07-14

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 36

Registration Number: NCT00002676

Locations: 🇺🇸
CCOP - Carle Cancer Center, Urbana, Illinois, United States
🇺🇸
Siouxland Hematology-Oncology, Sioux City, Iowa, United States
🇺🇸
CCOP - Kalamazoo, Kalamazoo, Michigan, United States

and more 18 locations

Radiation Therapy With or Without Chemotherapy in Treating Patients With Advanced Head and Neck Cancer

Phase 3

Completed

Conditions: Head and Neck Cancer

First Posted Date: 2004-06-09

Last Posted Date: 2013-08-02

Lead Sponsor: Cancer Research UK

Registration Number: NCT00002476

Locations: 🇬🇧
Derriford Hospital, Plymouth, England, United Kingdom
🇬🇧
Southend General Hospital, Westcliff-On-Sea, England, United Kingdom
🇬🇧
Royal Victoria Hospital, Belfast, Northern Ireland, United Kingdom

and more 4 locations