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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

The Chinese University of Hong Kong Early Arthritis Study

Not Applicable
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2009-05-14
Last Posted Date
2012-08-02
Lead Sponsor
Chinese University of Hong Kong
Target Recruit Count
40
Registration Number
NCT00901550
Locations
🇨🇳

The Prince of Wales Hospital, Hong Kong, China

🇨🇳

Prince of Wales Hospital, Hong Kong, China

🇨🇳

Department of Medicine and Therapeutics, Hong Kong, China

An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis

Phase 4
Completed
Conditions
Arthritis, Rheumatoid
Interventions
First Posted Date
2009-05-11
Last Posted Date
2013-09-13
Lead Sponsor
Xian-Janssen Pharmaceutical Ltd.
Target Recruit Count
234
Registration Number
NCT00896168

Pre-reinductive Decitabine and Vorinostat in Relapsed Lymphoblastic Lymphoma or Acute Lymphoblastic Leukemia

First Posted Date
2009-04-16
Last Posted Date
2017-12-28
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Target Recruit Count
15
Registration Number
NCT00882206
Locations
🇺🇸

University of Minnesota Amplatz Children's Hospital, Minneapolis, Minnesota, United States

Fludarabine, Bendamustine, and Rituximab in Treating Participants With Lymphoid Cancers Undergoing Stem Cell Transplant

Phase 1
Completed
Conditions
Follicular Lymphoma
Mantle Cell Lymphoma
CD20 Positive
Chronic Lymphocytic Leukemia
Marginal Zone Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
T-Cell Non-Hodgkin Lymphoma
Interventions
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Biological: Anti-Thymocyte Globulin
Drug: Bendamustine
Biological: Filgrastim
Drug: Fludarabine
Drug: Methotrexate
Biological: Rituximab
Drug: Tacrolimus
First Posted Date
2009-04-14
Last Posted Date
2019-06-03
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
60
Registration Number
NCT00880815
Locations
🇺🇸

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

Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma

First Posted Date
2009-04-08
Last Posted Date
2024-07-03
Lead Sponsor
University of Miami
Target Recruit Count
25
Registration Number
NCT00878254
Locations
🇺🇸

University of Miami, Miami, Florida, United States

Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Phase 2
Completed
Conditions
B-cell Childhood Acute Lymphoblastic Leukemia
Recurrent Adult Lymphoblastic Lymphoma
T-cell Adult Acute Lymphoblastic Leukemia
T-cell Childhood Acute Lymphoblastic Leukemia
Recurrent Adult Acute Lymphoblastic Leukemia
B-cell Adult Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Lymphoblastic Lymphoma
Interventions
First Posted Date
2009-04-01
Last Posted Date
2017-01-27
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
148
Registration Number
NCT00873093
Locations
🇺🇸

Lurie Children's Hospital-Chicago, Chicago, Illinois, United States

🇺🇸

University of Illinois, Chicago, Illinois, United States

🇺🇸

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

and more 168 locations

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

Phase 3
Completed
Conditions
Myeloid Neoplasm
Childhood Acute Promyelocytic Leukemia With PML-RARA
Interventions
First Posted Date
2009-03-23
Last Posted Date
2022-10-25
Lead Sponsor
Children's Oncology Group
Target Recruit Count
106
Registration Number
NCT00866918
Locations
🇺🇸

Overlook Hospital, Summit, New Jersey, United States

🇺🇸

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States

🇺🇸

Valley Children's Hospital, Madera, California, United States

and more 118 locations

Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)

Phase 1
Completed
Conditions
Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia
Childhood B Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2009-03-20
Last Posted Date
2021-04-27
Lead Sponsor
Children's Oncology Group
Target Recruit Count
104
Registration Number
NCT00866307
Locations
🇺🇸

Children's Hospital Los Angeles, Los Angeles, California, United States

🇺🇸

Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States

🇺🇸

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States

and more 25 locations

Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma

First Posted Date
2009-03-20
Last Posted Date
2019-09-10
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
120
Registration Number
NCT00866749
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia

Phase 2
Completed
Conditions
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Childhood Chronic Myelogenous Leukemia
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Childhood Acute Lymphoblastic Leukemia in Remission
Childhood Myelodysplastic Syndromes
Interventions
Drug: treosulfan
Drug: fludarabine phosphate
Radiation: total-body irradiation
Procedure: peripheral blood stem cell transplantation
Drug: tacrolimus
Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Drug: methotrexate
First Posted Date
2009-03-12
Last Posted Date
2021-06-22
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
96
Registration Number
NCT00860574
Locations
🇺🇸

University of Colorado, Denver, Colorado, United States

🇺🇸

Oregon Health and Science University, Portland, Oregon, United States

🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

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