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

Treatment of Acute Lymphoblastic Leukemia in Children

Phase 3

Completed

Conditions: Drug/Agent Toxicity by Tissue/Organ
Leukemia

Interventions: Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexrazoxane hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: etoposide
Drug: mercaptopurine
Drug: methotrexate
Drug: pegaspargase
Drug: methylprednisolone
Drug: prednisolone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Radiation: radiation therapy

First Posted Date: 2006-11-17

Last Posted Date: 2024-11-27

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 800

Registration Number: NCT00400946

Locations: 🇨🇦
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada
🇺🇸
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States
🇨🇦
Centre de Recherche du Centre Hospitalier de l'Universite Laval, Sainte Foy, Quebec, Canada

and more 5 locations

BBBD Followed By Methotrexate and Carboplatin With or Without Trastuzumab in Treating Women With Breast Cancer That Has Spread to the Brain

Phase 1

Withdrawn

Conditions: Drug/Agent Toxicity by Tissue/Organ
Cognitive/Functional Effects
Brain and Central Nervous System Tumors
Breast Cancer
Psychosocial Effects of Cancer and Its Treatment

Interventions: Drug: carboplatin
Biological: trastuzumab
Drug: methotrexate
Drug: sodium thiosulfate

First Posted Date: 2006-11-09

Last Posted Date: 2017-04-21

Lead Sponsor: OHSU Knight Cancer Institute

Registration Number: NCT00397501

A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study

Phase 4

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Infliximab, methylprednisolone, methotrexate
Drug: Methotrexate + Methylprednisolone
Drug: Methotrexate + Infliximab
Drug: Methotrexate

First Posted Date: 2006-11-07

Last Posted Date: 2007-10-19

Lead Sponsor: Université Catholique de Louvain

Target Recruit Count: 45

Registration Number: NCT00396747

Locations: 🇧🇪
Université catholique de Louvain, Brussels, Belgium

Combination Chemotherapy With or Without Etoposide Followed By an Autologous Stem Cell Transplant in Treating Young Patients With Previously Untreated Malignant Brain Tumors

Phase 3

Conditions: Brain and Central Nervous System Tumors

Interventions: Drug: carboplatin
Drug: temozolomide
Drug: cisplatin
Drug: thiotepa
Drug: cyclophosphamide
Drug: vincristine sulfate
Drug: etoposide
Procedure: autologous bone marrow transplantation
Drug: methotrexate
Procedure: autologous hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy

First Posted Date: 2006-10-26

Last Posted Date: 2013-12-18

Lead Sponsor: Children's Hospital Los Angeles

Target Recruit Count: 120

Registration Number: NCT00392886

Locations: 🇺🇸
Childrens Hospital Los Angeles, Los Angeles, California, United States
🇦🇺
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
🇺🇸
Children's Hospital of Orange County, Orange, California, United States

and more 34 locations

Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma

Phase 2

Completed

Conditions: Lymphoma

Interventions: Biological: filgrastim
Biological: pegfilgrastim
Biological: rituximab
Drug: cyclophosphamide
Drug: cytarabine
Drug: etoposide
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Drug: leucovorin calcium
Drug: liposomal cytarabine
Drug: methotrexate
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate

First Posted Date: 2006-10-26

Last Posted Date: 2018-06-06

Lead Sponsor: AIDS Malignancy Consortium

Target Recruit Count: 34

Registration Number: NCT00392834

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
🇺🇸
UCLA Clinical AIDS Research and Education (CARE) Center, Los Angeles, California, United States
🇺🇸
Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center, Seattle, Washington, United States

and more 10 locations

Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.

Phase 2

Completed

Conditions: BCR-ABL1 Fusion Protein Expression
Recurrent Acute Lymphoblastic Leukemia
t(9;22)
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Philadelphia Chromosome Positive
Acute Lymphoblastic Leukemia

Interventions: Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dasatinib
Drug: Dexamethasone
Drug: Doxorubicin
Drug: Methotrexate
Drug: Prednisone
Drug: Vincristine

First Posted Date: 2006-10-20

Last Posted Date: 2024-02-07

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 107

Registration Number: NCT00390793

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease

Phase 2

Completed

Conditions: Hodgkin's Disease

Interventions: Drug: Gemcitabine
Drug: Fludarabine
Drug: Melphalan
Drug: Antithymocyte Globulin
Procedure: Allogeneic Stem Cell Infusion
Drug: Tacrolimus
Drug: Filgrastim (G-CSF)
Drug: Methotrexate

First Posted Date: 2006-10-11

Last Posted Date: 2018-05-09

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 52

Registration Number: NCT00385788

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia in Complete Remission

Phase 3

Completed

Conditions: L2 Childhood Acute Lymphoblastic Leukemia
Childhood Acute Lymphoblastic Leukemia in Remission
L1 Childhood Acute Lymphoblastic Leukemia
Graft Versus Host Disease
T-cell Childhood Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia

Interventions: Drug: thiotepa
Drug: cyclophosphamide
Drug: tacrolimus
Drug: methotrexate
Drug: sirolimus
Radiation: total body irradiation

First Posted Date: 2006-09-28

Last Posted Date: 2019-08-07

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 146

Registration Number: NCT00382109

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇨🇦
Hospital for Sick Children, Toronto, Ontario, Canada
🇺🇸
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

and more 47 locations

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

Phase 3

Completed

Conditions: L1 Childhood Acute Lymphoblastic Leukemia
L2 Childhood Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia
Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia

Interventions: Drug: vincristine sulfate
Drug: prednisone
Drug: doxorubicin hydrochloride
Drug: pegaspargase
Drug: cytarabine
Drug: methotrexate
Drug: dexamethasone
Drug: etoposide
Drug: cyclophosphamide
Drug: leucovorin calcium
Biological: filgrastim
Drug: asparaginase
Drug: mercaptopurine

First Posted Date: 2006-09-28

Last Posted Date: 2024-03-26

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 275

Registration Number: NCT00381680

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
🇺🇸
Childrens Memorial Hospital, Chicago, Illinois, United States

and more 170 locations

Clofarabine and Cytarabine in Treating Young Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Phase 1

Completed

Conditions: Leukemia

Interventions: Drug: clofarabine
Drug: cytarabine
Drug: methotrexate
Other: laboratory biomarker analysis

First Posted Date: 2006-09-07

Last Posted Date: 2017-06-05

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 74

Registration Number: NCT00372619

Locations: 🇨🇦
Hospital for Sick Children, Toronto, Ontario, Canada
🇺🇸
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
🇺🇸
Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States

and more 76 locations

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