MedPath

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

Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia in Complete Remission

Phase 3
Completed
Conditions
L2 Childhood Acute Lymphoblastic Leukemia
Childhood Acute Lymphoblastic Leukemia in Remission
L1 Childhood Acute Lymphoblastic Leukemia
Graft Versus Host Disease
T-cell Childhood Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2006-09-28
Last Posted Date
2019-08-07
Lead Sponsor
Children's Oncology Group
Target Recruit Count
146
Registration Number
NCT00382109
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

🇨🇦

Hospital for Sick Children, Toronto, Ontario, Canada

🇺🇸

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

and more 47 locations

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

Phase 3
Completed
Conditions
L1 Childhood Acute Lymphoblastic Leukemia
L2 Childhood Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia
Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2006-09-28
Last Posted Date
2024-03-26
Lead Sponsor
Children's Oncology Group
Target Recruit Count
275
Registration Number
NCT00381680
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

🇺🇸

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States

🇺🇸

Childrens Memorial Hospital, Chicago, Illinois, United States

and more 170 locations

Clofarabine and Cytarabine in Treating Young Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Phase 1
Completed
Conditions
Leukemia
Interventions
Drug: clofarabine
Drug: cytarabine
Drug: methotrexate
Other: laboratory biomarker analysis
First Posted Date
2006-09-07
Last Posted Date
2017-06-05
Lead Sponsor
Children's Oncology Group
Target Recruit Count
74
Registration Number
NCT00372619
Locations
🇨🇦

Hospital for Sick Children, Toronto, Ontario, Canada

🇺🇸

CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States

🇺🇸

Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States

and more 76 locations

Bortezomib Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Blood Stem Cell Transplantation

Phase 1
Completed
Conditions
Hematologic Malignancies
Interventions
Drug: Bortezomib (Velcade)
Drug: Tacrolimus
Drug: Methotrexate
Procedure: blood stem cell transplantation
First Posted Date
2006-08-29
Last Posted Date
2013-07-25
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
45
Registration Number
NCT00369226
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy

Phase 1
Completed
Conditions
Psoriasis
Interventions
Drug: Methotrexate
Drug: Raptiva
First Posted Date
2006-08-25
Last Posted Date
2018-06-14
Lead Sponsor
University of California, Davis
Target Recruit Count
12
Registration Number
NCT00368654
Locations
🇺🇸

University of California, Davis Medical Center Department of Dermatology, Sacramento, California, United States

A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.

Phase 1
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2006-08-16
Last Posted Date
2010-06-11
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
23
Registration Number
NCT00365001

A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2006-08-08
Last Posted Date
2014-07-29
Lead Sponsor
Centocor, Inc.
Target Recruit Count
643
Registration Number
NCT00361335

Methotrexate and Glucocorticoids in Treating Patients With Newly Diagnosed Acute Graft-Versus-Host Disease After Donor Stem Cell Transplant

Phase 2
Completed
Conditions
Cancer
First Posted Date
2006-07-27
Last Posted Date
2010-09-14
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
53
Registration Number
NCT00357084
Locations
🇺🇸

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

Combination Chemotherapy With or Without Surgery & Chemoradiotherapy in Patients With Malignant Pleural Mesothelioma

Phase 2
Completed
Conditions
Malignant Mesothelioma
Interventions
Drug: Cisplatin
Drug: Methotrexate
Drug: Vinorelbine ditartrate
Procedure: Adjuvant therapy
Procedure: Conventional surgery
Procedure: Neoadjuvant Therapy
Radiation: 3-dimensional conformal radiation therapy
Radiation: Intensity-modulated radiation therapy
First Posted Date
2006-07-20
Last Posted Date
2023-08-31
Lead Sponsor
The Cleveland Clinic
Target Recruit Count
9
Registration Number
NCT00354393
Locations
🇺🇸

Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Ifosfamide, Carboplatin, Etoposide, and SGN-30 in Treating Young Patients With Recurrent Anaplastic Large Cell Lymphoma

Phase 1
Terminated
Conditions
Anaplastic Large Cell Lymphoma
Recurrent Childhood Anaplastic Large Cell Lymphoma
Interventions
Biological: monoclonal antibody SGN-30
Drug: therapeutic hydrocortisone
Drug: ifosfamide
Drug: carboplatin
Drug: etoposide
Drug: methotrexate
Drug: cytarabine
Other: pharmacological study
Other: laboratory biomarker analysis
First Posted Date
2006-07-20
Last Posted Date
2018-03-14
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
5
Registration Number
NCT00354107
Locations
🇺🇸

Children's Oncology Group, Philadelphia, Pennsylvania, United States

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