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

German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 4
Completed
Conditions
Adult Acute Lymphocytic Leukemia
Interventions
First Posted Date
2005-09-20
Last Posted Date
2023-03-20
Lead Sponsor
Goethe University
Target Recruit Count
377
Registration Number
NCT00198978
Locations
🇩🇪

University of Frankfurt, Medical Dept. II, Frankfurt, Germany

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)

Phase 4
Completed
Conditions
Adult Acute Lymphocytic Leukemia
First Posted Date
2005-09-20
Last Posted Date
2023-03-17
Lead Sponsor
Goethe University
Target Recruit Count
720
Registration Number
NCT00199069
Locations
🇩🇪

University Hospital, Medical Dept. II, Frankfurt, Germany

Newly Diagnosed Mature B-ALL, Burkitt's Lymphoma and Other High-grade Lymphoma in Adults

Phase 4
Completed
Conditions
Burkitt's Lymphoma
Burkitt's Leukemia
Mediastinal Neoplasms
Lymphoblastic Lymphoma
Large Cell Anaplastic Lymphoma
Interventions
Drug: Adriamycin
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone/Prednisolone
Drug: VP16
Drug: Ifosfamide
Drug: Methotrexate
Drug: G-CSF
Drug: Rituximab
Drug: Vincristine/Vindesine
Procedure: Irradiation (in specific conditions)
First Posted Date
2005-09-20
Last Posted Date
2022-08-19
Lead Sponsor
Nicola Goekbuget
Target Recruit Count
650
Registration Number
NCT00199082
Locations
🇩🇪

University Hospital, Medical Dept. II, Frankfurt, Germany

Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab

Phase 4
Completed
Conditions
Adult Acute Lymphocytic Leukemia
First Posted Date
2005-09-20
Last Posted Date
2010-08-23
Lead Sponsor
Johann Wolfgang Goethe University Hospital
Target Recruit Count
60
Registration Number
NCT00199004
Locations
🇩🇪

University Hospital of Frankfurt, Medical Dept. II, Frankfurt, Germany

Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia

Phase 4
Completed
Conditions
Adult Acute Lymphocytic Leukemia
First Posted Date
2005-09-20
Last Posted Date
2023-03-20
Lead Sponsor
Goethe University
Target Recruit Count
40
Registration Number
NCT00199095
Locations
🇩🇪

University Hospital, Medical Dept. II, Frankfurt, Germany

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)

Phase 4
Completed
Conditions
Adult Acute Lymphocytic Leukemia
First Posted Date
2005-09-20
Last Posted Date
2023-03-20
Lead Sponsor
Goethe University
Target Recruit Count
225
Registration Number
NCT00199056
Locations
🇩🇪

University Hospital, Medical Dept. II, Frankfurt, Germany

Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2005-09-19
Last Posted Date
2012-09-05
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
542
Registration Number
NCT00195494

Two-Dose Methotrexate for Ectopic Pregnancy

Phase 3
Completed
Conditions
Ectopic Pregnancy
First Posted Date
2005-09-19
Last Posted Date
2011-08-09
Lead Sponsor
University of Pennsylvania
Target Recruit Count
100
Registration Number
NCT00194272
Locations
🇺🇸

University of Miami, Miami, Florida, United States

🇺🇸

University of Southern California Women's and Children's Hospital, Los Angeles, California, United States

🇺🇸

University of Pennsylvania Reproductive Research Unit, Philadelphia, Pennsylvania, United States

Weekly Docetaxel and CMF in the Adjuvant Treatment of Elderly Women With High-Risk Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2005-09-19
Last Posted Date
2011-05-03
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
150
Registration Number
NCT00193011

Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer

Phase 2
Terminated
Conditions
Estrogen Receptor-positive Breast Cancer
Stage IIIA Breast Cancer
HER2-negative Breast Cancer
Progesterone Receptor-positive Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer
Interventions
Drug: exemestane
Drug: triptorelin pamoate
Drug: capecitabine
Drug: methotrexate
Drug: vinorelbine tartrate
Drug: paclitaxel
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Other: laboratory biomarker analysis
First Posted Date
2005-09-19
Last Posted Date
2017-07-11
Lead Sponsor
University of Washington
Target Recruit Count
28
Registration Number
NCT00194792
Locations
🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

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