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Therapy Name Methotrexate
Synonyms
Therapy Description

Methotrexate is an antimetabolite, which inhibits DHFR resulting in decreased immune function and antineoplastic activity and is FDA approved for psoriasis, RA, and several cancers including choriocarcinoma, AML, lung, head and neck and epidermoid (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Methotrexate Abitrexate Amethopterin Chemotherapy - Antimetabolite 14 Methotrexate is an antimetabolite, which inhibits DHFR resulting in decreased immune function and antineoplastic activity and is FDA approved for psoriasis, RA, and several cancers including choriocarcinoma, AML, lung, head and neck and epidermoid (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT00030264 Phase II Vinblastine Methotrexate Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas Completed USA 0
NCT00267865 Phase II Rituximab Methotrexate Leucovorin Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma Completed USA 0
NCT00513474 Phase I Rasburicase Methotrexate Sirolimus Cyclosporine Tacrolimus Filgrastim Busulfan + Cyclophosphamide + Etoposide Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant Completed USA 0
NCT03856216 Phase II Methotrexate Filgrastim + Methotrexate + Rituximab Rituximab Bendamustine + Fludarabine + Inotuzumab ozogamicin + Tacrolimus Filgrastim + Methotrexate Inotuzumab ozogamicin Fludarabine + Inotuzumab ozogamicin + Melphalan + Tacrolimus anti-thymocyte globulin Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation Recruiting USA 0
NCT01529827 Phase II Melphalan Methotrexate Tacrolimus Mycophenolate mofetil Fludarabine Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies Completed USA 0
NCT03117751 Phase II Cyclophosphamide Vincristine Sulfate Idarubicin Blinatumomab Doxorubicin Clofarabine Vorinostat Ruxolitinib Prednisone Bortezomib Etoposide Dasatinib Daunorubicin Dexamethasone Rituximab Methotrexate Cytarabine Mercaptopurine Pegaspargase Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma Active, not recruiting USA | AUS 0
NCT02553460 Phase II Cyclophosphamide Mitoxantrone Dexamethasone Bortezomib Etoposide Vincristine Sulfate Pegaspargase Vorinostat Cytarabine Methotrexate Leucovorin Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I Active, not recruiting USA | CAN 0
NCT03769506 Phase III Methotrexate Cetuximab ASP-1929 Docetaxel Paclitaxel ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy Recruiting USA 3
NCT01187810 Phase I Fenretinide Cytarabine Methotrexate Fenretinide in Children With Recurrent/Resistant ALL, AML, and NHL Terminated USA 0
NCT06496178 Phase III Methotrexate Cetuximab Docetaxel MCLA-158 A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients Recruiting USA | ISR | AUS | ARG 3
NCT01338987 Phase II Tacrolimus Busulfan Methotrexate Leuprolide Cyclophosphamide Fludarabine Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation Completed USA 0
NCT00549848 Phase III Daunorubicin + Pegaspargase + Vincristine Sulfate Cytarabine Mercaptopurine Thioguanine Clofarabine + Cyclophosphamide + Etoposide Methotrexate Dasatinib Doxorubicin Dexamethasone Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia Completed USA 0
NCT05848687 Phase Ib/II Bortezomib Dexamethasone Blinatumomab Vorinostat Mercaptopurine Pegaspargase Methotrexate Ziftomenib Mitoxantrone TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II Recruiting USA | CAN 0
NCT01614197 Phase I Etoposide Cyclophosphamide Prednisone Cytarabine Temsirolimus Methotrexate A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma Completed USA | CAN | AUS 0
NCT03860844 Phase II Idarubicin Cyclophosphamide Isatuximab Doxorubicin Etoposide Daunoxome Cytarabine Methotrexate Daunorubicin Fludarabine Dexamethasone Mitoxantrone Filgrastim Vincristine Sulfate Pegaspargase Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia Terminated USA | SWE | NOR | NLD | ITA | HUN | GRC | FRA | DNK | DEU | BRA | ARG 4
NCT02105636 Phase III Methotrexate Cetuximab Docetaxel Nivolumab Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141) Completed USA | NLD | ITA | GBR | FRA | ESP | DEU | CHE | CAN | BRA | ARG 4
NCT00621036 Phase II Methotrexate Thiotepa Sargramostim Vaccine Therapy and GM-CSF in Treating Patients With CNS Lymphoma Withdrawn USA 0
NCT03571321 Phase I Pegaspargase Methotrexate Cytarabine Mercaptopurine Thioguanine Ruxolitinib Cyclophosphamide Dexamethasone Vincristine Sulfate Rituximab Doxorubicin Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia Recruiting USA 0
NCT02043587 Phase II Rituximab Pegaspargase Methotrexate Cytarabine Leucovorin Cyclophosphamide Dasatinib Daunorubicin Vincristine Sulfate Etoposide Chemotherapy With Liposomal Cytarabine CNS Prophylaxis for Adult Acute Lymphoblastic Leukemia & Lymphoblastic Lymphoma Terminated USA 0
NCT02883049 Phase III Dasatinib Dexamethasone + Doxorubicin Prednisone Vincristine Sulfate Thioguanine Cytarabine Mercaptopurine Leucovorin Methotrexate Pegaspargase Etoposide Clofarabine Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations Active, not recruiting USA | NZL | IRL | CHE | CAN | AUS 1
NCT03147612 Phase II Pegfilgrastim Blinatumomab Vincristine Sulfate Rituximab Filgrastim Ponatinib Cyclophosphamide Methotrexate Cytarabine Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia Active, not recruiting USA 0
NCT02076997 Phase I Methotrexate Individualized High Dose Methotrexate to Treat Cancer in Children Who Have a Significant Risk for Side Effects to Methotrexate Completed USA 0
NCT02458339 Phase I Methotrexate Methotrexate Infusion Into Fourth Ventricle in Children With Recurrent Malignant Fourth Ventricular Brain Tumors Completed USA 0
NCT00003553 Phase II Cyclophosphamide + Fludarabine Cyclosporine Mycophenolate mofetil Methotrexate Peripheral Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer Completed USA 0
NCT02251821 Phase II Fludarabine Tacrolimus Mycophenolate mofetil Busulfan Pacritinib Momelotinib Melphalan Methotrexate Ruxolitinib Cyclophosphamide JAK-2 Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis Active, not recruiting USA 0
NCT00857389 Phase II Cyclophosphamide Filgrastim Tacrolimus Thiotepa anti-thymocyte globulin + Busulfan + Clofarabine Methotrexate Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies Completed USA 0
NCT02551718 Phase I Bosutinib Irinotecan Romidepsin Busulfan Melphalan Nilotinib Crizotinib Cytarabine Mitoxantrone Dasatinib Pazopanib Paclitaxel Clofarabine Hydroxyurea Tretinoin Carfilzomib Nelarabine Bexarotene Pentostatin Everolimus Cabozantinib Mercaptopurine Methotrexate Cladribine Thioguanine Daunorubicin Ponatinib Etoposide Afatinib Gefitinib Gemcitabine Regorafenib Arsenic trioxide Trametinib Imatinib Erlotinib Dabrafenib Decitabine Axitinib Azacitidine Ruxolitinib Fludarabine Lapatinib Ceritinib Sirolimus Sorafenib Lomustine Sunitinib Cabazitaxel Temsirolimus Topotecan Bortezomib Pralatrexate High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia Completed USA 0
NCT02419755 Phase II Cytarabine Mercaptopurine Methotrexate Pegaspargase Vorinostat Doxorubicin Bortezomib Dexamethasone Mitoxantrone Prednisone Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies Terminated USA 0
NCT02252042 Phase III Pembrolizumab Methotrexate Cetuximab Docetaxel Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040) Completed 0
NCT04029688 Phase Ib/II Idasanutlin + Venetoclax Cyclophosphamide + Idasanutlin + Topotecan Cytarabine + Fludarabine + Idasanutlin Cytarabine + Hydrocortisone + Methotrexate Cytarabine Methotrexate Idasanutlin Cyclophosphamide + Idasanutlin A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors Completed USA | NLD | GBR | FRA | ESP | CAN 0
NCT03088059 Phase II Niraparib Durvalumab + Monalizumab Methotrexate Carboplatin Rogaratinib Mitomycin C Docetaxel Afatinib Paclitaxel Durvalumab Monalizumab Palbociclib Bleomycin Gemcitabine Fluorouracil Biomarker-based Study in R/M SCCHN (UPSTREAM) Active, not recruiting ITA | GBR | FRA | ESP | BEL 0
NCT01823198 Phase Ib/II Methotrexate anti-thymocyte globulin + Busulfan + Fludarabine Tacrolimus Filgrastim Natural Killer (NK) Cells With HLA Compatible Hematopoietic Transplantation for High Risk Myeloid Malignancies Completed USA 0
NCT03007147 Phase III Pegaspargase Methotrexate Leucovorin Cytarabine Mercaptopurine Thioguanine Vincristine Sulfate Cyclophosphamide Imatinib Ifosfamide Dexrazoxane Daunorubicin Dexamethasone Methylprednisolone Etoposide Prednisolone Doxorubicin Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Active, not recruiting USA | SWE | NZL | NLD | ITA | ISR | FRA | FIN | DEU | CZE | CHE | CAN | BEL | AUT | AUS 4
NCT03792256 Phase I Cytarabine + Hydrocortisone + Methotrexate Cytarabine + Doxorubicin + Palbociclib + Pegaspargase + Prednisone + Vincristine Sulfate Methotrexate Cytarabine + Doxorubicin + Palbociclib + Pegaspargase + Prednisolone + Vincristine Sulfate Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) Active, not recruiting USA 0
NCT01535053 Phase III Leucovorin Dactinomycin Methotrexate Methotrexate or Dactinomycin in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia Completed USA | GBR | CAN 2
NCT02788201 Phase II Erlotinib Thiotepa Imatinib Dacarbazine Arsenic trioxide Idarubicin Mitomycin C Thioguanine Mercaptopurine Methotrexate Cladribine Epirubicin Gemcitabine Doxorubicin Bleomycin Etoposide Gefitinib Daunorubicin Lomustine Sorafenib Sunitinib Ifosfamide Asparaginase Ixabepilone Abiraterone Azacitidine Ruxolitinib Decitabine Axitinib Estramustine Floxuridine Lapatinib Carmustine Fludarabine Nilotinib Cisplatin Vismodegib Vandetanib Melphalan Busulfan Carboplatin Toremifene Crizotinib Dactinomycin Temsirolimus Vorinostat Romidepsin Fluorouracil Irinotecan Bortezomib Tamoxifen Topotecan Chlorambucil Pentostatin Eribulin Carfilzomib Vemurafenib Hydroxyurea Exemestane Vincristine Sulfate Dasatinib Mitoxantrone Vinblastine Cytarabine Tretinoin Clofarabine Teniposide Docetaxel Pazopanib Oxaliplatin Streptozocin Paclitaxel Bendamustine Mechlorethamine Mitotane Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma Completed USA 0
NCT03319901 Phase I Cytarabine Mercaptopurine Methotrexate Cyclophosphamide Venetoclax Doxorubicin Etoposide Vincristine Sulfate Venetoclax and Chemotherapy In ALL Recruiting USA 0
NCT05725200 Phase II Dasatinib Palbociclib Gemcitabine Trastuzumab Cetuximab Pertuzumab Panobinostat Alectinib Venetoclax Larotrectinib Encorafenib Everolimus Idelalisib Crizotinib Pembrolizumab Methotrexate Talazoparib Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer (EVIDENT) Recruiting NOR 0
NCT02881086 Phase III Rituximab Doxorubicin Cytarabine Mercaptopurine Nelarabine Methotrexate Pegaspargase Cyclophosphamide Vindesine Vincristine Sulfate Daunorubicin Dexamethasone Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment Active, not recruiting DEU 0
NCT03962465 Phase I Daunorubicin + Inotuzumab ozogamicin + Pegaspargase + Prednisone + Vincristine Sulfate Daunorubicin + Inotuzumab ozogamicin + Prednisone + Vincristine Sulfate Cytarabine Methotrexate Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL (ALL-001) Active, not recruiting USA 0
NCT03020030 Phase III Nelarabine Dexrazoxane Asparaginase Vincristine Sulfate Cyclophosphamide Cytarabine Mercaptopurine Pegaspargase Methotrexate Etoposide Doxorubicin Dexamethasone Prednisone Dasatinib Leucovorin Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents Active, not recruiting USA | CAN 0
NCT01483690 Phase Ib/II Pegaspargase Methotrexate Dexamethasone Vincristine Sulfate Decitabine Mitoxantrone A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL Terminated USA | AUS 0
NCT02535806 Phase II Vincristine Sulfate Bortezomib Pegaspargase Methotrexate Cytarabine Mitoxantrone Prednisone Four Drug Reinduction With Bortezomib for Relapsed or Refractory ALL or LL in Children and Young Adults Terminated USA 0
NCT01790568 Phase II Methotrexate Tacrolimus Vorinostat Vorinostat Plus Tacrolimus & Methotrexate to Prevent Graft vs Host Disease Following Unrelated Stem Cell Transplant Completed USA 0
NCT02112916 Phase III Cyclophosphamide Vincristine Sulfate Ifosfamide Pegaspargase Methotrexate Cytarabine Mercaptopurine Thioguanine Leucovorin Daunorubicin Dexamethasone Bortezomib Etoposide Doxorubicin 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 Active, not recruiting USA | NZL | CAN | AUS 0
NCT03150693 Phase III Rituximab Doxorubicin Mercaptopurine Methotrexate Cyclophosphamide + Cytarabine Thioguanine Allopurinol Daunorubicin Dexamethasone Vincristine Sulfate Inotuzumab ozogamicin Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia Suspended USA | CAN 0


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