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

Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission

Phase 2

Completed

Conditions: Leukemia

Interventions: Biological: filgrastim
Drug: busulfan
Drug: cytarabine
Drug: etoposide
Drug: methotrexate
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2004-04-22

Last Posted Date: 2016-06-28

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 51

Registration Number: NCT00002768

Locations: 🇺🇸
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
🇺🇸
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
🇺🇸
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, United States

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS Lymphoma

Phase 2

Completed

Conditions: Lymphoma

First Posted Date: 2004-04-14

Last Posted Date: 2012-07-02

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 50

Registration Number: NCT00003061

Locations: 🇧🇪
U.Z. Gasthuisberg, Leuven, Belgium
🇫🇷
Institut Gustave Roussy, Villejuif, France
🇳🇱
Rotterdam Cancer Institute, Rotterdam, Netherlands

and more 4 locations

Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer

Phase 3

Completed

Conditions: Cervical Cancer

First Posted Date: 2004-04-14

Last Posted Date: 2012-07-11

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 700

Registration Number: NCT00003209

Locations: 🇬🇧
Derbyshire Royal Infirmary, Derby, England, United Kingdom
🇬🇧
Beatson Oncology Centre, Glasgow, Scotland, United Kingdom

Monoclonal Antibody Therapy, Cyclophosphamide, and Total-Body Irradiation Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Recurrent Acute Lymphocytic Leukemia

Phase 2

Completed

Conditions: Leukemia

First Posted Date: 2004-04-14

Last Posted Date: 2010-04-02

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 40

Registration Number: NCT00003870

Locations: 🇺🇸
University of Washington Medical Center, Seattle, Washington, United States
🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer

Phase 2

Conditions: Breast Cancer

First Posted Date: 2004-04-13

Last Posted Date: 2014-01-06

Lead Sponsor: Herbert Irving Comprehensive Cancer Center

Registration Number: NCT00012311

Locations: 🇺🇸
Herbert Irving Comprehensive Cancer Center, New York, New York, United States

Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium

Phase 3

Completed

Conditions: Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Bladder Cancer

First Posted Date: 2004-04-09

Last Posted Date: 2023-06-22

Lead Sponsor: Eastern Cooperative Oncology Group

Target Recruit Count: 330

Registration Number: NCT00003376

Locations: 🇺🇸
University of Illinois at Chicago Health Sciences Center, Chicago, Illinois, United States
🇺🇸
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States
🇺🇸
University of Chicago Cancer Research Center, Chicago, Illinois, United States

and more 47 locations

OTI-010 for Graft-Versus-Host Disease Prophylaxis in Treating Patients Who Are Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies

Phase 2

Withdrawn

Conditions: Myelodysplastic Syndromes
Graft Versus Host Disease
Leukemia

First Posted Date: 2004-04-08

Last Posted Date: 2014-12-04

Lead Sponsor: Mesoblast International Sàrl

Registration Number: NCT00081055

Locations: 🇺🇸
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer

Phase 3

Completed

Conditions: Breast Cancer

First Posted Date: 2004-04-06

Last Posted Date: 2013-11-06

Lead Sponsor: Scottish Cancer Therapy Network

Target Recruit Count: 1000

Registration Number: NCT00003012

Locations: 🇬🇧
Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom
🇬🇧
Royal Alexandra Hospital, Paisley, Scotland, United Kingdom
🇬🇧
Western General Hospital, Edinburgh, Scotland, United Kingdom

and more 7 locations

Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia

Phase 2

Completed

Conditions: Leukemia
Lymphoma

Interventions: Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: leucovorin calcium
Drug: mesna
Drug: methotrexate
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET photon therapy

First Posted Date: 2004-04-06

Last Posted Date: 2016-07-04

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 134

Registration Number: NCT00002494

Locations: 🇺🇸
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
🇺🇸
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
🇺🇸
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States

and more 20 locations

Gemtuzumab Ozogamicin, Fludarabine, and Total-body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Leukemia
Myelodysplastic Syndromes

First Posted Date: 2004-03-25

Last Posted Date: 2010-04-02

Lead Sponsor: Fred Hutchinson Cancer Center

Registration Number: NCT00008151

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

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