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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

Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia

Phase 2
Active, not recruiting
Conditions
Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Recurrent Acute Lymphoblastic Leukemia
Refractory Acute Lymphoblastic Leukemia
Interventions
Procedure: Biopsy
Procedure: Biospecimen Collection
Biological: Blinatumomab
Procedure: Bone Marrow Aspiration and Biopsy
Procedure: Computed Tomography
Procedure: Echocardiography
Drug: Dasatinib
Procedure: Lumbar Puncture
Procedure: Magnetic Resonance Imaging
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Methotrexate Sodium
Drug: Prednisone
Drug: Vincristine
Drug: Vincristine Sulfate
Procedure: X-Ray Imaging
First Posted Date
2014-05-21
Last Posted Date
2024-12-27
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
53
Registration Number
NCT02143414
Locations
🇺🇸

Springfield Memorial Hospital, Springfield, Illinois, United States

🇺🇸

University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States

🇺🇸

John L McClellan Memorial Veterans Hospital, Little Rock, Arkansas, United States

and more 194 locations

Targeted Marrow Irradiation, Fludarabine Phosphate, and Busulfan Before Donor Progenitor Cell Transplant in Treating Patients With Hematologic Malignancies

Phase 1
Completed
Conditions
Acute Myeloid Leukemia
Acute Lymphocytic Leukemia
Myeloproliferative Syndrome
Non Hodgkin Lymphoma
Hodgkin Lymphoma
Myelodysplastic Syndrome
Hematologic Malignancies
Multiple Myeloma
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Interventions
Radiation: total marrow irradiation
Drug: fludarabine phosphate
Drug: busulfan
Procedure: myeloid progenitor cell transplantation
Biological: anti-thymocyte globulin
Drug: tacrolimus
Drug: methotrexate
Other: laboratory biomarker analysis
First Posted Date
2014-05-02
Last Posted Date
2021-05-07
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
14
Registration Number
NCT02129582
Locations
🇺🇸

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Low-dose Methotrexate for Change in Global Initiative for Asthma Step 5 Medications in Chronic Severe Asthma

Phase 3
Conditions
Low Dose Methotrexate in Severe Chronic Asthma
Interventions
Drug: Placebo
Drug: Methotrexate
First Posted Date
2014-04-28
Last Posted Date
2021-09-28
Lead Sponsor
Universita degli Studi di Catania
Target Recruit Count
102
Registration Number
NCT02124226

Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies

Phase 1
Completed
Conditions
Recurrent Adult Acute Myeloid Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Secondary Myelodysplastic Syndromes
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Previously Treated Myelodysplastic Syndromes
Untreated Adult Acute Lymphoblastic Leukemia
Interventions
Radiation: radiation therapy
Drug: cyclophosphamide
Biological: anti-thymocyte globulin
Drug: tacrolimus
Drug: methotrexate
Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Other: laboratory biomarker analysis
First Posted Date
2014-04-24
Last Posted Date
2023-09-21
Lead Sponsor
Sumithira Vasu
Target Recruit Count
33
Registration Number
NCT02122081
Locations
🇺🇸

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States

4 x Epirubicin, Cyclophosphamide, Followed by 4 x Docetaxel Versus 6 x CMF / 6 x CEF

First Posted Date
2014-04-15
Last Posted Date
2019-10-03
Lead Sponsor
West German Study Group
Target Recruit Count
2011
Registration Number
NCT02115204
Locations
🇩🇪

Ev. Hospital Bethesda, Moenchengladbach, Germany

Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors

Phase 2
Active, not recruiting
Conditions
Atypical Teratoid Rhabdoid Tumor
Malignant Rhabdoid Tumor
Interventions
First Posted Date
2014-04-15
Last Posted Date
2024-10-31
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
125
Registration Number
NCT02114229
Locations
🇺🇸

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

🇺🇸

Texas Children's Hospital, Houston, Texas, United States

🇺🇸

Lucille Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California, United States

and more 6 locations

Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma

Phase 3
Active, not recruiting
Conditions
Adult T Acute Lymphoblastic Leukemia
Ann Arbor Stage II Adult Lymphoblastic Lymphoma
Ann Arbor Stage II Childhood Lymphoblastic Lymphoma
Ann Arbor Stage III Adult Lymphoblastic Lymphoma
Ann Arbor Stage III Childhood Lymphoblastic Lymphoma
Ann Arbor Stage IV Adult Lymphoblastic Lymphoma
Ann Arbor Stage IV Childhood Lymphoblastic Lymphoma
Childhood T Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2014-04-14
Last Posted Date
2025-01-07
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
847
Registration Number
NCT02112916
Locations
🇺🇸

Covenant Children's Hospital, Lubbock, Texas, United States

🇺🇸

UMC Cancer Center / UMC Health System, Lubbock, Texas, United States

🇦🇺

Monash Medical Center-Clayton Campus, Clayton, Victoria, Australia

and more 209 locations

Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)

Phase 3
Completed
Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
First Posted Date
2014-04-07
Last Posted Date
2022-10-05
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
361
Registration Number
NCT02105636
Locations
🇨🇳

Local Institution - 0064, Taipei, Taiwan

🇨🇭

Local Institution - 0051, Zuerich, Switzerland

🇺🇸

Local Institution - 0004, Metairie, Louisiana, United States

and more 44 locations

Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia

First Posted Date
2014-04-02
Last Posted Date
2024-12-27
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
669
Registration Number
NCT02101853
Locations
🇺🇸

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

🇺🇸

NYP/Weill Cornell Medical Center, New York, New York, United States

🇺🇸

State University of New York Upstate Medical University, Syracuse, New York, United States

and more 183 locations

A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2014-03-27
Last Posted Date
2016-11-03
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
341
Registration Number
NCT02097745
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