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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

Natural Killer (NK) Cell Adback After Allogeneic Stem Cell Transplant With Campath-IH Plus Chemorx for Patients With Lymphoid Malignancies

Phase 2
Completed
Conditions
Leukemia
Lymphoma
Interventions
Drug: ARA-C
Drug: BCNU
Drug: Campath-1H
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Fludarabine
Drug: Melphalan
Drug: Rituximab
Other: Allogeneic Stem Cell Transplantation
Radiation: Total body radiation (TBI)
Drug: Methotrexate
Drug: Tacrolimus
Procedure: Adback NK or T Cell
First Posted Date
2007-09-28
Last Posted Date
2020-09-24
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
22
Registration Number
NCT00536978
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2007-09-26
Last Posted Date
2017-07-26
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
132
Registration Number
NCT00535782
Locations
🇺🇸

Rheumatology Associates of North Alabama, Huntsville, Alabama, United States

🇺🇸

Pinnacle Research Group; Llc, Central, Anniston, Alabama, United States

🇺🇸

Arthritis & Rheumatism; Disease Specialities, Aventura, Florida, United States

and more 37 locations

LAL-BR/2001: Study Treatment to Low Risk ALL

Phase 4
Completed
Conditions
Acute Lymphoblastic Leukemia
First Posted Date
2007-09-10
Last Posted Date
2016-01-20
Lead Sponsor
PETHEMA Foundation
Target Recruit Count
150
Registration Number
NCT00526175
Locations
🇪🇸

Basurtuko Ospitalea, Basurto, Spain

🇪🇸

Complejo Hospitalario Universitario de Albacete, Albacete, Spain

🇪🇸

Hospital General de Alicante, Alicante, Spain

and more 22 locations

LAL-AR-N-2005:Study Treatment for Children High Risk Acute Lymphoblastic Leukemia

Phase 4
Completed
Conditions
Acute Lymphoblastic Leukemia
First Posted Date
2007-09-10
Last Posted Date
2014-10-28
Lead Sponsor
PETHEMA Foundation
Target Recruit Count
40
Registration Number
NCT00526409
Locations
🇪🇸

Hospital Niño Jesús, Madrid, Spain

🇪🇸

Hospital materno Infantil vall d'Hebrón, Barcelona, Spain

🇪🇸

Hospital Infantil Carlos Haya, Málaga, Spain

and more 1 locations

Donor Stem Cell Transplant After Conditioning Therapy in Treating Patients With Hematologic Cancer, Recurrent or Metastatic Solid Tumor, or Other Disease

Not Applicable
Completed
Conditions
Nonmalignant Neoplasm
Multiple Myeloma and Plasma Cell Neoplasm
Lymphoma
Leukemia
Unspecified Adult Solid Tumor, Protocol Specific
Myelodysplastic Syndromes
First Posted Date
2007-08-27
Last Posted Date
2013-03-26
Lead Sponsor
Asan Medical Center
Target Recruit Count
30
Registration Number
NCT00521430
Locations
🇰🇷

Asan Medical Center - University of Ulsan College of Medicine, Seoul, Korea, Republic of

A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.

Phase 2
Terminated
Conditions
Lymphoma
Interventions
First Posted Date
2007-08-17
Last Posted Date
2014-08-08
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
5
Registration Number
NCT00517699

Gene Expression Profiling in Patients With Invasive Bladder Cancer Receiving Methotrexate, Vinblastine, Doxorubicin, and Cisplatin

Phase 2
Terminated
Conditions
Bladder Cancer
First Posted Date
2007-08-15
Last Posted Date
2013-07-10
Lead Sponsor
Kyoto University
Target Recruit Count
100
Registration Number
NCT00516750
Locations
🇯🇵

Shiga Medical Center for Adults, Moriyama, Shiga, Japan

🇯🇵

Nagoya University Hospital, Nagoya, Aichi, Japan

🇯🇵

Kyoto University Hospital, Kyoto, Japan

and more 2 locations

High-Dose Methotrexate in Treating Young Patients With Solid Tumors

Phase 1
Completed
Conditions
Brain and Central Nervous System Tumors
Sarcoma
Unspecified Childhood Solid Tumor, Protocol Specific
First Posted Date
2007-08-09
Last Posted Date
2013-06-26
Lead Sponsor
Children's Cancer and Leukaemia Group
Target Recruit Count
36
Registration Number
NCT00513981
Locations
🇬🇧

Royal Manchester Children's Hospital, Manchester, England, United Kingdom

🇮🇪

Our Lady's Hospital for Sick Children Crumlin, Dublin, Ireland

🇬🇧

Birmingham Children's Hospital, Birmingham, England, United Kingdom

and more 17 locations

Combination Chemotherapy and Denileukin Diftitox in Treating Patients With Newly Diagnosed T-Cell Non-Hodgkin Lymphoma

Not Applicable
Withdrawn
Conditions
Lymphoma
First Posted Date
2007-08-08
Last Posted Date
2016-12-15
Lead Sponsor
University of Miami
Registration Number
NCT00513188
Locations
🇺🇸

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States

Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant

Phase 1
Completed
Conditions
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Interventions
Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporin-A
Drug: etoposide
Drug: methotrexate
Drug: rasburicase
Drug: sirolimus
Procedure: allogeneic hematopoietic stem cell transplantation
Drug: tacrolimus
Procedure: peripheral blood stem cell transplantation
Radiation: total-body irradiation
Drug: fludarabine
Drug: allopurinol
First Posted Date
2007-08-08
Last Posted Date
2017-05-25
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
46
Registration Number
NCT00513474
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

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