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

Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow Transplant

Phase 2

Completed

Conditions: Aplastic Anemia

Interventions: Drug: cyclophosphamide
Biological: anti-thymocyte globulin
Drug: cyclosporine
Procedure: allogeneic bone marrow transplantation
Drug: methotrexate
Genetic: DNA analysis
Other: flow cytometry
Genetic: polymorphism analysis
Other: laboratory biomarker analysis

First Posted Date: 2006-06-23

Last Posted Date: 2017-04-13

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 21

Registration Number: NCT00343785

Locations: 🇺🇸
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States
🇺🇸
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma

Phase 3

Active, not recruiting

Conditions: Medulloblastoma
Anaplastic Medulloblastoma
Supratentorial Embryonal Tumor, Not Otherwise Specified
Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor

Interventions: Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Etoposide
Biological: Filgrastim
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Drug: Leucovorin Calcium
Drug: Thiotepa
Drug: Methotrexate
Drug: Vincristine Sulfate

First Posted Date: 2006-06-12

Last Posted Date: 2024-09-30

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 91

Registration Number: NCT00336024

Locations: 🇺🇸
Tulane University School of Medicine, New Orleans, Louisiana, United States
🇺🇸
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids, Michigan, United States
🇺🇸
NYU Langone Hospital - Long Island, Mineola, New York, United States

and more 142 locations

Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma

Phase 2

Terminated

Conditions: Lymphoma

Interventions: Biological: Rituximab
Drug: Cytarabine
Drug: Dexamethasone
Drug: Leucovorin
Drug: Methotrexate
Drug: Procarbazine
Drug: Vincristine

First Posted Date: 2006-06-08

Last Posted Date: 2023-07-03

Lead Sponsor: Eastern Cooperative Oncology Group

Target Recruit Count: 26

Registration Number: NCT00335140

Locations: 🇺🇸
West Michigan Cancer Center, Kalamazoo, Michigan, United States
🇺🇸
Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States
🇺🇸
Bronson Methodist Hospital, Kalamazoo, Michigan, United States

and more 65 locations

Combination Chemotherapy Followed By Donor Stem Cell Transplant in Treating Patients With Hemophagocytic Lymphohistiocytosis

Phase 3

Conditions: Nonneoplastic Condition

First Posted Date: 2006-06-08

Last Posted Date: 2013-09-17

Lead Sponsor: Children's Cancer and Leukaemia Group

Target Recruit Count: 288

Registration Number: NCT00334672

Locations: 🇬🇧
Birmingham Children's Hospital, Birmingham, England, United Kingdom
🇬🇧
Watford General Hospital, Herts, England, United Kingdom
🇬🇧
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

and more 9 locations

ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: docetaxel
Drug: cyclophosphamide
Drug: methotrexate
Drug: 5-fluorouracil

First Posted Date: 2006-05-29

Last Posted Date: 2017-03-28

Lead Sponsor: National Cancer Institute, Naples

Target Recruit Count: 300

Registration Number: NCT00331097

Locations: 🇮🇹
Azienda Ospedaliera G. Rummo, Benevento, BN, Italy
🇮🇹
Policlinico Monteluce, Sant'Andrea delle Frate, PG, Italy
🇮🇹
Università Federico II, Cattedra di Oncologia Medica, Napoli, Italy

and more 5 locations

Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia

Phase 3

Completed

Conditions: Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Myelodysplastic Syndrome With Isolated Del(5q)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Previously Treated Myelodysplastic Syndromes
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Acute Myeloid Leukemia/Transient Myeloproliferative Disorder
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)

Interventions: Radiation: total-body irradiation
Procedure: allogeneic hematopoietic stem cell transplantation
Drug: mycophenolate mofetil
Drug: cyclophosphamide
Drug: cyclosporine
Drug: busulfan
Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Other: laboratory biomarker analysis
Genetic: cytogenetic analysis
Other: flow cytometry
Other: pharmacological study
Genetic: fluorescence in situ hybridization
Drug: tacrolimus
Genetic: polymorphism analysis
Drug: methotrexate

First Posted Date: 2006-05-04

Last Posted Date: 2014-10-31

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 25

Registration Number: NCT00322101

Locations: 🇺🇸
Weill Cornell University, New York, New York, United States
🇺🇸
HealthOne Presbyterian St. Lukes Medical Center, Denver, Colorado, United States
🇺🇸
Emory University, Altanta, Georgia, United States

and more 5 locations

Cyclophosphamide in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Fanconi's Anemia

Phase 1

Completed

Conditions: Fanconi Anemia

First Posted Date: 2006-04-25

Last Posted Date: 2012-04-20

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 25

Registration Number: NCT00317876

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
🇧🇷
Universidade Federal do Parana, Curitiba, Parana, Brazil
🇺🇸
Seattle Cancer Care Alliance, Seattle, Washington, United States

Total-Body Irradiation and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer and Other Diseases

Phase 2

Completed

Conditions: Leukemia
Lymphoma
Myelodysplastic Syndromes

First Posted Date: 2006-04-25

Last Posted Date: 2010-05-07

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 50

Registration Number: NCT00317785

Locations: 🇺🇸
Seattle Cancer Care Alliance, Seattle, Washington, United States
🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma

Not Applicable

Conditions: Lymphoma

First Posted Date: 2006-04-24

Last Posted Date: 2015-09-25

Lead Sponsor: European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma

Target Recruit Count: 96

Registration Number: NCT00317408

Locations: 🇨🇿
University Hospital Brno, Brno, Czech Republic
🇧🇪
U.Z. Gasthuisberg, Leuven, Belgium
🇩🇪
Krankenhaus Muenchen Schwabing, Munich, Germany

and more 91 locations

Melphalan and Busulfan Followed By Donor Peripheral Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

First Posted Date: 2006-04-12

Last Posted Date: 2010-09-21

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 20

Registration Number: NCT00313625

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

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