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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

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2007-12-19
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
60
Registration Number
NCT00576433

Combination Chemotherapy Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or High-Risk Primary Refractory Hodgkin Lymphoma

Phase 2
Completed
Conditions
Lymphoma
Interventions
Drug: cyclophosphamide
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: gemcitabine hydrochloride
Drug: ifosfamide
Drug: mechlorethamine hydrochloride
Drug: melphalan
Drug: methotrexate
Drug: mycophenolate mofetil
Drug: prednisone
Drug: procarbazine hydrochloride
Drug: vincristine sulfate
Drug: vinorelbine tartrate
Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Procedure: umbilical cord blood transplantation
Radiation: total-body irradiation
First Posted Date
2007-12-17
Last Posted Date
2023-09-28
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
25
Registration Number
NCT00574496
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

Phase 4
Completed
Conditions
Arthritis, Rheumatoid
Interventions
First Posted Date
2007-11-30
Last Posted Date
2015-08-10
Lead Sponsor
Pfizer
Target Recruit Count
834
Registration Number
NCT00565409
Locations
🇬🇧

Pfizer Investigational Site, Dudley, West Midlands, United Kingdom

Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 3
Completed
Conditions
Acute Undifferentiated Leukemia
Acute Lymphoblastic Leukemia
Childhood T Acute Lymphoblastic Leukemia
Interventions
Drug: Asparaginase
Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Procedure: Echocardiography
Drug: Etoposide
Biological: Filgrastim
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Lestaurtinib
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Methylprednisolone
Procedure: Multigated Acquisition Scan
Drug: Pegaspargase
Other: Pharmacological Study
Drug: Prednisone
Drug: Therapeutic Hydrocortisone
Drug: Vincristine Sulfate
First Posted Date
2007-11-12
Last Posted Date
2024-07-15
Lead Sponsor
Children's Oncology Group
Target Recruit Count
218
Registration Number
NCT00557193
Locations
🇺🇸

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

🇺🇸

Connecticut Children's Medical Center, Hartford, Connecticut, United States

🇺🇸

MedStar Georgetown University Hospital, Washington, District of Columbia, United States

and more 167 locations

Alemtuzumab, Busulfan, and Cyclophosphamide Followed By a Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

Phase 1
Terminated
Conditions
Graft Versus Host Disease
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Interventions
Biological: alemtuzumab
Drug: busulfan
Drug: cyclophosphamide
Drug: methotrexate
Drug: tacrolimus
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
First Posted Date
2007-11-07
Last Posted Date
2017-05-24
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
1
Registration Number
NCT00555048
Locations
🇺🇸

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

🇺🇸

Seattle Cancer Care Alliance, Seattle, Washington, United States

Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous Leukemia

Phase 2
Completed
Conditions
Leukemia
Interventions
Biological: anti-thymocyte globulin
Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: methotrexate
Drug: methylprednisolone
Drug: tacrolimus
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
First Posted Date
2007-11-04
Last Posted Date
2020-04-16
Lead Sponsor
Children's Oncology Group
Target Recruit Count
158
Registration Number
NCT00553202
Locations
🇺🇸

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia, United States

🇺🇸

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States

🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

and more 49 locations

S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

First Posted Date
2007-10-31
Last Posted Date
2023-01-10
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
78
Registration Number
NCT00551460
Locations
🇺🇸

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States

🇺🇸

Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States

🇺🇸

Saint Louis University Cancer Center, Saint Louis, Missouri, United States

and more 189 locations

Different Therapies in Treating Infants With Newly Diagnosed Acute Leukemia

Not Applicable
Conditions
Leukemia
First Posted Date
2007-10-30
Last Posted Date
2019-07-30
Lead Sponsor
Dutch Childhood Oncology Group
Target Recruit Count
445
Registration Number
NCT00550992
Locations
🇨🇿

University Hospital Motol, Prague, Czechia

🇫🇷

CHR Hotel Dieu, Nantes, France

🇺🇸

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States

and more 10 locations

Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders

Phase 2
Active, not recruiting
Conditions
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Precancerous/Nonmalignant Condition
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Interventions
Drug: cyclosporine
Drug: cyclophosphamide
Drug: busulfan
Drug: etoposide
Drug: fludarabine phosphate
Drug: melphalan
Drug: methotrexate
Drug: mycophenolate mofetil
Drug: sirolimus
Drug: tacrolimus
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: total-body irradiation
First Posted Date
2007-10-16
Last Posted Date
2024-04-02
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
260
Registration Number
NCT00544115
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