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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

Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Phase 4
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2012-03-08
Last Posted Date
2016-02-23
Lead Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Target Recruit Count
910
Registration Number
NCT01548001
Locations
🇨🇳

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China

Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia

Phase 3
Completed
Conditions
Choriocarcinoma
FIGO Stage I Gestational Trophoblastic Tumor
FIGO Stage II Gestational Trophoblastic Tumor
FIGO Stage III Gestational Trophoblastic Tumor
Hydatidiform Mole
Interventions
Biological: Dactinomycin
Drug: Leucovorin Calcium
Other: Quality-of-Life Assessment
Drug: Methotrexate
First Posted Date
2012-02-17
Last Posted Date
2022-08-12
Lead Sponsor
GOG Foundation
Target Recruit Count
57
Registration Number
NCT01535053
Locations
🇺🇸

Temple University Hospital, Philadelphia, Pennsylvania, United States

🇺🇸

Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States

🇺🇸

Columbus Oncology and Hematology Associates Inc, Columbus, Ohio, United States

and more 286 locations

Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Phase 2
Completed
Conditions
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Myeloid Leukemia in Remission
Childhood Acute Myeloid Leukemia in Remission
Childhood Chronic Myelogenous Leukemia
Childhood Grade III Lymphomatoid Granulomatosis
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Interventions
Drug: fludarabine phosphate
Drug: melphalan
Radiation: total-body irradiation
Drug: tacrolimus
Drug: mycophenolate mofetil
Drug: methotrexate
Other: laboratory biomarker analysis
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
First Posted Date
2012-02-09
Last Posted Date
2019-09-24
Lead Sponsor
Roswell Park Cancer Institute
Target Recruit Count
94
Registration Number
NCT01529827
Locations
🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

Study Comparing Two Treatments in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Phase 2
Completed
Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
First Posted Date
2012-02-07
Last Posted Date
2017-06-14
Lead Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Target Recruit Count
101
Registration Number
NCT01528163
Locations
🇧🇪

Grand Hôpital de Charleroi, Charleroi, Hainaut, Belgium

🇱🇺

Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg

🇧🇪

Hôpital de Jolimont, Haine-Saint-Paul, Hainaut, Belgium

and more 13 locations

Ofatumumab in Combination With Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate, and Dexamethasone Alternating With Ofatumumab in Combination With Cytarabine and Methotrexate in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

Phase 2
Completed
Conditions
Stage I Mantle Cell Lymphoma
Stage II Contiguous Mantle Cell Lymphoma
Stage II Non-Contiguous Mantle Cell Lymphoma
Stage III Mantle Cell Lymphoma
Stage IV Mantle Cell Lymphoma
Interventions
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Methotrexate
Biological: Ofatumumab
Drug: Vincristine Sulfate
First Posted Date
2012-02-06
Last Posted Date
2024-02-07
Lead Sponsor
Roswell Park Cancer Institute
Target Recruit Count
37
Registration Number
NCT01527149
Locations
🇺🇸

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)

Phase 2
Terminated
Conditions
Leukemia
Lymphoma
Myeloma
Myeloproliferative Diseases
Interventions
Drug: Fludarabine
Drug: Melphalan
Drug: Alemtuzumab
Procedure: Stem Cell Infusion
Drug: Tacrolimus
Drug: Methotrexate
Drug: G-CSF
Procedure: Low Dose Donor T-Cells
Procedure: High Dose Donor T-Cells
First Posted Date
2012-01-25
Last Posted Date
2016-03-17
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
16
Registration Number
NCT01518153
Locations
🇺🇸

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

Safety & Efficacy of Atorvastatin for Prophylaxis of Acute Graft Versus Host Disease in Patients With Hematological Malignancies HLA- Donor Hematopoietic Stem Cell Transplantation

Phase 2
Completed
Conditions
Acute Lymphocytic Leukemia
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Interventions
First Posted Date
2011-12-14
Last Posted Date
2018-01-23
Lead Sponsor
Ohio State University Comprehensive Cancer Center
Target Recruit Count
40
Registration Number
NCT01491958
Locations
🇺🇸

Ohio State University, Columbus, Ohio, United States

Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT)

Phase 2
Completed
Conditions
Leukemia
Lymphoma
Interventions
First Posted Date
2011-12-13
Last Posted Date
2020-05-05
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
20
Registration Number
NCT01490723
Locations
🇺🇸

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

A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL

Phase 1
Terminated
Conditions
Acute Lymphoblastic Leukemia
Precursor B-Cell Lymphoblastic Leukemia
Precursor T-Cell Lymphoblastic Leukemia
Interventions
First Posted Date
2011-12-01
Last Posted Date
2020-10-27
Lead Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Target Recruit Count
23
Registration Number
NCT01483690
Locations
🇺🇸

Seattle Children's Hospital, Seattle, Washington, United States

🇦🇺

Children's Hospital at Westmead, Westmead, New South Wales, Australia

🇦🇺

Sydney Children's Hospital, Sydney, Australia

and more 25 locations

Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients

Phase 2
Completed
Conditions
Diffuse Large B Cell Lymphoma
Interventions
Drug: Ofatumumab
Drug: Etoposide
Drug: Ifosfamid
Drug: Mesna
Drug: Cytarabine
Drug: Methotrexate
Drug: Leukovorin
Drug: Granulocyte-Colony Stimulating Factor
First Posted Date
2011-11-29
Last Posted Date
2021-12-27
Lead Sponsor
Polish Lymphoma Research Group
Target Recruit Count
77
Registration Number
NCT01481272
Locations
🇵🇱

Instytut Hematologii i Transfuzjologii, Warszawa, Mazowieckie, Poland

🇵🇱

Dolnośląskie Centrum Transplantacji Komórkowych, Wrocław, Dolnośląskie, Poland

🇵🇱

Uniwersyteckie Cenrum Medyczne, Gdańsk, Pomorskie, Poland

and more 5 locations
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