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 ca...

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.
...

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

Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia

Phase 3

Completed

Conditions: Leukemia

First Posted Date: 2003-01-27

Last Posted Date: 2014-02-20

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 276

Registration Number: NCT00005603

Locations: 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 17 locations

Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes

Phase 2

Completed

Conditions: Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Leukemia

Interventions: Drug: Cyclosporine
Drug: Methotrexate
Drug: Photopheresis
Drug: Mycofenolate mofetil
Drug: Pentostatin
Procedure: allogeneic bone marrow
Procedure: peripheral blood stem cell
Radiation: Total body irradiation

First Posted Date: 2003-01-27

Last Posted Date: 2023-06-28

Lead Sponsor: Eastern Cooperative Oncology Group

Target Recruit Count: 17

Registration Number: NCT00045305

Locations: 🇺🇸
Jewish Hospital Cancer Center, Cincinnati, Ohio, United States
🇺🇸
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
🇺🇸
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States

and more 3 locations

Induction Intensification in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Leukemia

Interventions: Biological: filgrastim
Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate

First Posted Date: 2003-01-27

Last Posted Date: 2014-02-14

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 221

Registration Number: NCT00002756

Locations: 🇺🇸
Children's Hospital Central California, Madera, California, United States
🇺🇸
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
🇺🇸
Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida, United States

and more 137 locations

Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Advanced Hematologic Cancer

Phase 2

Completed

Conditions: Graft Versus Host Disease
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms

First Posted Date: 2003-01-27

Last Posted Date: 2013-03-07

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT00014469

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Combination Chemotherapy in Treating Children With Anaplastic Large Cell Lymphoma (ALCL 99)

Phase 3

Completed

Conditions: Lymphoma

First Posted Date: 2003-01-27

Last Posted Date: 2022-05-31

Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Target Recruit Count: 885

Registration Number: NCT00006455

Locations: 🇫🇷
Institut Gustave Roussy, Villejuif, France
🇦🇹
St. Anna Children's Hospital, Vienna, Austria
🇩🇪
Kinderklinik, Giessen, Germany

and more 7 locations

Combination Chemotherapy Followed by Radiation Therapy in Treating Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Ependymoma

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2003-01-27

Last Posted Date: 2013-07-18

Lead Sponsor: Children's Hospital Los Angeles

Registration Number: NCT00006258

Locations: 🇺🇸
Geisinger Medical Center, Danville, Pennsylvania, United States
🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇨🇦
Tom Baker Cancer Centre - Calgary, Calgary, Alberta, Canada

Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer

Phase 2

Withdrawn

Conditions: Stage IV Breast Cancer
Recurrent Breast Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2013-07-10

Lead Sponsor: Burzynski Research Institute

Registration Number: NCT00003536

Locations: 🇺🇸
Burzynski Clinic, Houston, Texas, United States

Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome

Phase 3

Completed

Conditions: Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms

Interventions: Drug: cytarabine
Drug: asparaginase
Drug: daunorubicin hydrochloride
Drug: methotrexate
Drug: therapeutic hydrocortisone
Drug: thioguanine

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-27

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 254

Registration Number: NCT00003593

Locations: 🇺🇸
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
🇺🇸
Naval Medical Center, Portsmouth, Portsmouth, Virginia, United States
🇺🇸
Children's Memorial Hospital - Chicago, Chicago, Illinois, United States

and more 233 locations

Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium

Phase 2

Completed

Conditions: Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-12

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 238

Registration Number: NCT00014274

Locations: 🇳🇱
Academisch Medisch Centrum at University of Amsterdam, Amsterdam, Netherlands
🇧🇪
Institut Jules Bordet, Brussels, Belgium
🇳🇱
Universitair Medisch Centrum St. Radboud - Nijmegen, Nijmegen, Netherlands

and more 26 locations

Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia

Phase 3

Completed

Conditions: Leukemia
Lymphoma

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-12

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 392

Registration Number: NCT00002700

Locations: 🇸🇰
Institute of Hematology & Transfusiology, University Hospital, Bratislava, Slovakia
🇧🇪
Hopital Universitaire Erasme, Brussels, Belgium
🇧🇪
Universitair Ziekenhuis Antwerpen, Edegem, Belgium

and more 41 locations

Drug Development Updates

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