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 Methotrexate

Methotrexate is an antimetabolite and antifolate agent with antineoplastic and immunosuppressant activities. Methotrexate binds to and inhibits the enzyme dihydrofolate reductase, resulting in inhibition of purine nucleotide and thymidylate synthesis and, subsequently, inhibition of DNA and RNA syntheses. Methotrexate also exhibits potent immunosuppressant activity although the mechanism(s) of actions is unclear. Check for active clinical trials or closed clinical trials using this agent. (NCI Thesaurus)

Trexall™ (methotrexate tablets), for oral administration, are available in 5 mg, 7.5 mg, 10 mg and 15 mg strengths. Each tablet contains methotrexate sodium in an amount equivalent to the labeled amount of methotrexate, and contains the following inactive ingredients: anhydrous lactose, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium carbonate monohydrate, talc and titanium dioxide. The 5 mg also contains: D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake and FD&C yellow no. 6 aluminum lake. The 7.5 mg also contains: FD&C blue no.1 aluminum lake. The 10 mg also contains: FD&C red no. 40 aluminum lake. The 15 mg also contains: FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake.

Accordinng to http://en.wikipedia.org/wiki/Methotrexate, In 1947, a team of researchers led by Sidney Farber showed that aminopterin, a chemical analogue of folic acid developed by Yellapragada Subbarao Lederle, could induce remission in children with acute lymphoblastic leukemia. The development of folic acid analogues had been prompted by the discovery that the administration of folic acid worsened leukemia, and that a diet deficient in folic acid could, conversely, produce improvement; the mechanism of action behind these effects was still unknown at the time. Other analogues of folic acid were in development, and by 1950, methotrexate (then known as amethopterin) was being proposed as a treatment for leukemia. Animal studies published in 1956 showed that the therapeutic index of methotrexate was better than that of aminopterin, and clinical use of aminopterin was thus abandoned in favor of methotrexate. In that same year, methotrexate was found to be a curative treatment for choriocarcinoma—a solid tumor, unlike leukemia, which is a cancer of the blood. The drug was then investigated as a treatment for many other cancers, alone or in combination with other drugs, and was studied for other, non-cancer indications in the 1970s. In 1988, it was approved by the U.S. Food and Drug Administration (FDA) to treat rheumatoid arthritis.

Methotrexate was originally used as part of combination chemotherapy regimens to treat many kinds of cancers. It is still the mainstay for the treatment of many neoplastic disorders including acute lymphoblastic leukemia.

Methotrexate is commonly used (generally in combination with misoprostol) to terminate early pregnancies (i.e. as an abortifacient). It is also used to treat ectopic pregnancies.[6] In the case of early missed miscarriage (particularly a blighted ovum), in which fetal demise has occurred but the body has not expelled the fetus, methotrexate may be used to help the body begin the miscarriage process.
[edit] Other uses

It has come into use as a treatment for some autoimmune diseases, including Myasthenia Gravis, polymyositis, dermatomyositis, inclusion body myositis, ankylosing spondylitis, Crohn's disease, psoriasis, pustular psoriasis, psoriatic arthritis, rheumatoid arthritis, Wegener's granulomatosis, Adult-Onset Still's Disease, and scleroderma (see disease-modifying antirheumatic drugs). A parallel use with TNFα blockers, such as adalimumab, infliximab, or etanercept, has been shown to markedly improve symptoms.

It is also sometimes used to treat a rare condition called Behçet's disease where it is taken weekly, along with folic acid daily. In the case of immune disorders, such as Behçet's disease and rheumatoid disorders, it is believed that the clinical goal of the low dose methotrexate regimen is to inhibit AICAR transformylase, which leads to increased AICA ribose (AICAR transformylase's substrate). The AICA ribose inhibits adenosine deaminase, resulting in a build-up of extracellular adenosine. Extracellular adenosine inhibits the expression of IL-2 receptors on circulating T-lymphocytes, causing a suppression of the immune system, and thus ameliorating the effects of the immune disorder.

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516: Ohtsu T, Ishida Y, Tobinai K, Minato K, Hamada H, Ohkochi E, Tsuruo T, Shimoyama M. A novel multidrug resistance in cultured leukemia and lymphoma cells detected by a monoclonal antibody to 85-kDa protein, MRK20. Jpn J Cancer Res. 1989 Nov;80(11):1133-40. PubMed PMID: 2514173.

517: Zylicz Z, Hofs HP, Wagener DJ, Van Rennes H, Wessels JM, van den Broek LA, Ottenheijm HC. Modulation of the in vitro cytotoxicity of seven anticancer drugs by protein synthesis inhibition using sparsomycin. Anticancer Res. 1989 Nov-Dec;9(6):1835-40. PubMed PMID: 2483308.

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519: Tanaka H, Yamamuro T, Kotoura Y, Matsumoto M, Tanaká C, Suzuki S, Tsuzi T, Miki T. 1 alpha,25(OH)2D3 exerts cytostatic effects on murine osteosarcoma cells and enhances the cytocidal effects of anticancer drugs. Clin Orthop Relat Res. 1989 Oct;(247):290-6. PubMed PMID: 2791395.

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523: Hannan MA, al-Dakan AA, Hussain SS, Amer MH. Mutagenicity of cisplatin and carboplatin used alone and in combination with four other anticancer drugs. Toxicology. 1989 Apr;55(1-2):183-91. PubMed PMID: 2652378.

524: Kooistra KL, Rodriguez M, Powis G. Toxicity of intrathecally administered cytotoxic drugs and their antitumor activity against an intrathecal Walker 256 carcinosarcoma model for meningeal carcinomatosis in the rat. Cancer Res. 1989 Feb 15;49(4):977-82. PubMed PMID: 2912564.

525: Pajari U. Effect of the antineoplastic agents doxorubicin and methotrexate on rat caries and secondary dentin formation. Scand J Dent Res. 1989 Feb;97(1):14-9. PubMed PMID: 2711120.

526: Baguley BC, Calveley SB, Crowe KK, Fray LM, O'Rourke SA, Smith GP. Comparison of the effects of flavone acetic acid, fostriecin, homoharringtonine and tumour necrosis factor alpha on colon 38 tumours in mice. Eur J Cancer Clin Oncol. 1989 Feb;25(2):263-9. PubMed PMID: 2702981.

527: Yanovski JA, Packer RJ, Levine JD, Davidson TL, Micalizzi M, D'Angio G. An animal model to detect the neuropsychological toxicity of anticancer agents. Med Pediatr Oncol. 1989;17(3):216-21. PubMed PMID: 2787469.

528: Ambaye RY, Indap MA, Naik SD. Enhanced activity of anticancer drugs in murine tumours by co-administration with 3-amino-pyrrolidine-2,5-dione-N-mustard derivative. J Cancer Res Clin Oncol. 1989;115(4):379-82. PubMed PMID: 2760102.

529: Tomita K, Tsuchiya H, Nomura S. Overall results of adjuvant chemotherapy and a chemosensitivity test for osteosarcoma. Clin Ther. 1989;11(1):135-42. PubMed PMID: 2720724.

530: Chang SY, Yu DS, Ma CP, Han SH, Yeh MY. In vitro chemosensitivity assay of human urologic malignancies. Eur Urol. 1989;16(1):51-6. PubMed PMID: 2714319.

531: Evans WE, Relling MV, Rodman JH, Crom WR. Anticancer therapy as a pediatric pharmacodynamic paradigm. Dev Pharmacol Ther. 1989;13(2-4):85-95. Review. PubMed PMID: 2693007.

532: Kao JW, Collins JL. A rapid in vitro screening system for the identification and evaluation of anticancer drugs. Cancer Invest. 1989;7(4):303-11. PubMed PMID: 2590857.

533: Tomita K, Tsuchiya H. Caffeine enhancement of the effect of anticancer agents on human sarcoma cells. Jpn J Cancer Res. 1989 Jan;80(1):83-8. PubMed PMID: 2496063.

534: Orlowski S, Belehradek J Jr, Paoletti C, Mir LM. Transient electropermeabilization of cells in culture. Increase of the cytotoxicity of anticancer drugs. Biochem Pharmacol. 1988 Dec 15;37(24):4727-33. PubMed PMID: 2462423.

535: Kiyohara T, Taniguchi K, Kubota S, Koga S, Sakuragi T, Saitoh Y. Induction of lymphokine-activated killer-like cells by cancer chemotherapy. J Exp Med. 1988 Dec 1;168(6):2355-60. PubMed PMID: 3199072; PubMed Central PMCID: PMC2189131.

536: Kovacic P, Ames JR, Taylor EC, Ryan MD. Electrochemistry of the anticancer agents methotrexate and alpha-difluoromethylornithine in iminium form. J Pharm Sci. 1988 Dec;77(12):999-1002. PubMed PMID: 3149673.

537: Kris MG, Kinahan JJ, Gralla RJ, Fanucchi MP, Wertheim MS, O'Connell JP, Marks LD, Williams L, Farag F, Young CW, et al. Phase I trial and clinical pharmacological evaluation of 10-ethyl-10-deazaaminopterin in adult patients with advanced cancer. Cancer Res. 1988 Oct 1;48(19):5573-9. PubMed PMID: 3416310.

538: Fujimoto T. [Combination of radio-chemotherapy for curing of childhood hematologic tumors: preventive approaches and problems on CNS involvement]. Gan No Rinsho. 1988 Oct;34(13):1903-8. Japanese. PubMed PMID: 3199522.

539: Gudewicz PW. Effect of anticancer drugs on macrophage-mediated antibody-dependent cytotoxicity and secretion of reactive oxygen intermediates. Cancer Lett. 1988 Sep-Oct;42(1-2):67-72. PubMed PMID: 2846149.

540: Geyer JR, Pendergrass TW, Milstein JM, Bleyer WA. Eight drugs in one day chemotherapy in children with brain tumors: a critical toxicity appraisal. J Clin Oncol. 1988 Jun;6(6):996-1000. PubMed PMID: 3373269.

541: Kaneda S, Ando S, Aisaka K, Tawada T, Kokuho K, Sasaki S, Yoshida K. [A case of cervical pregnancy treated with anticancer drugs]. Nippon Sanka Fujinka Gakkai Zasshi. 1988 May;40(5):669-71. Japanese. PubMed PMID: 3385285.

542: Fujii T, Maeda M. [Basic and clinical study of anticancer effect of etoposide on choriocarcinoma]. Nippon Sanka Fujinka Gakkai Zasshi. 1988 May;40(5):593-600. Japanese. PubMed PMID: 3385278.

543: van Dongen G, Braakhuis BJ, Bagnay M, Leyva A, Snow GB. Activity of differentiation-inducing agents and conventional drugs in head and neck cancer xenografts. Acta Otolaryngol. 1988 May-Jun;105(5-6):488-93. PubMed PMID: 2456664.

544: Ferguson LR, Turner PM. 'Petite' mutagenesis by anticancer drugs in Saccharomyces cerevisiae. Eur J Cancer Clin Oncol. 1988 Apr;24(4):591-6. PubMed PMID: 3289944.

545: Kraus JL, Pernice P, Ponce C. Inhibition of glyoxalase I by various clinically used anticancer drugs. Res Commun Chem Pathol Pharmacol. 1988 Mar;59(3):419-22. PubMed PMID: 3363227.

546: Levine MN, Gent M, Hirsh J, Arnold A, Goodyear MD, Hryniuk W, De Pauw S. The thrombogenic effect of anticancer drug therapy in women with stage II breast cancer. N Engl J Med. 1988 Feb 18;318(7):404-7. PubMed PMID: 3340118.

547: Gilli RM, Sari JC, Sica LM, Briand CM. Thermodynamic study of the influence of NADPH on the binding of methotrexate and its metabolites to a mammalian dihydrofolate reductase. Biochim Biophys Acta. 1988 Jan 12;964(1):53-60. PubMed PMID: 3334873.

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549: Singh M, Faulkner G, Ghose TI, Mezei M. Antibody directed targeting of methotrexate-containing small unilamellar vesicles. Cancer Immunol Immunother. 1988;27(1):17-25. PubMed PMID: 3293779.

550: Prevot J, Poncelet T, Lemelle JL, Lascombes P, Blanquart D, Membre H, Olive D. [Study of distraction osteogenesis in an animal body submitted to anticancer chemotherapy]. Chir Pediatr. 1988;29(4):226-30. French. PubMed PMID: 3168103.

551: Ozawa S, Yasuda T, Inaba M. Comparison of cellular basis of drug sensitivity of human colon, pancreatic, and renal carcinoma cell lines with that of leukemia cell lines. Cancer Chemother Pharmacol. 1988;22(1):41-6. PubMed PMID: 3165059.

552: Hussain SS, Amer MH, Hannan MA. Cytotoxicity of cisplatin and carboplatin used alone and in combination with the other anticancer drugs in the mouse embryo C3H10T1/2 cell line. Chemotherapy. 1988;34(6):504-11. PubMed PMID: 2468457.

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555: Petru E, Schmähl D. Anticancer drugs: second malignancies--risk reduction. Cancer Treat Rev. 1987 Dec;14(3-4):337-43. PubMed PMID: 3125969.

556: Douglas KT. The thymidylate synthesis cycle and anticancer drugs. Med Res Rev. 1987 Oct-Dec;7(4):441-75. Review. Erratum in: Med Res Rev 1989 Apr-Jun;9(2):following 265. PubMed PMID: 3309507.

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558: Ahmann FR, Garewal HS, Schifman R, Celniker A, Rodney S. Intracellular adenosine triphosphate as a measure of human tumor cell viability and drug modulated growth. In Vitro Cell Dev Biol. 1987 Jul;23(7):474-80. PubMed PMID: 3610945.

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560: Warrington RC, Cheng I, Fang WD. Effects of L-histidinol on the susceptibility of P815 mastocytoma cells to selected anticancer drugs in vitro and in DBA/2J mice. J Natl Cancer Inst. 1987 Jun;78(6):1177-83. PubMed PMID: 3108563.

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563: Kanamaru R, Kakuta H, Sato T, Ishioka C, Konishi Y, Wakui A, Dei T. [The metabolism of high-molecular-weight substances in cells and the effect of anticancer drugs]. Gan To Kagaku Ryoho. 1987 Mar;14(3 Pt 2):837-44. Japanese. PubMed PMID: 3566294.

564: Crom WR, Glynn-Barnhart AM, Rodman JH, Teresi ME, Kavanagh RE, Christensen ML, Relling MV, Evans WE. Pharmacokinetics of anticancer drugs in children. Clin Pharmacokinet. 1987 Mar;12(3):168-213. Review. PubMed PMID: 3555940.

565: Vitols KS, Montejano Y, Duffy T, Pope L, Grundler G, Huennekens FM. Platinum-folate compounds: synthesis, properties and biological activity. Adv Enzyme Regul. 1987;26:17-27. PubMed PMID: 3673704.

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567: Fry DW, Jackson RC. Biological and biochemical properties of new anticancer folate antagonists. Cancer Metastasis Rev. 1987;5(3):251-70. Review. PubMed PMID: 3549036.

568: Jackson RC. Unresolved issues in the biochemical pharmacology of antifolates. NCI Monogr. 1987;(5):9-15. Review. PubMed PMID: 3323909.

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573: Hill BT. Resistance of mammalian tumour cells to anticancer drugs: mechanisms and concepts relating specifically to methotrexate and vincristine. J Antimicrob Chemother. 1986 Oct;18 Suppl B:61-73. PubMed PMID: 3793664.

574: McMillan TJ, Hart IR. Enhanced experimental metastatic capacity of a murine melanoma following pre-treatment with anticancer drugs. Clin Exp Metastasis. 1986 Oct-Dec;4(4):285-92. PubMed PMID: 2431822.

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578: Balis FM. Pharmacokinetic drug interactions of commonly used anticancer drugs. Clin Pharmacokinet. 1986 May-Jun;11(3):223-35. Review. PubMed PMID: 2426030.

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580: Inoue K, Mukaiyama T, Yamazaki H, Horikoshi N, Ogawa M, Kobayashi T, Aiba K, Kuraishi Y. [Choice of second-line chemotherapy for advanced breast cancer based on the chemosensitivity assay by in vitro colony assay]. Gan To Kagaku Ryoho. 1986 Feb;13(2):356-61. Japanese. PubMed PMID: 3080968.

581: Kimoto Y. [Antitumor effect of interferons with chemotherapeutic agents]. Gan To Kagaku Ryoho. 1986 Feb;13(2):293-301. Japanese. PubMed PMID: 3080964.

582: Furusawa E, Furusawa S. Therapeutic potentials of pretazettine, standard anticancer drugs, and combinations on subcutaneously implanted Lewis lung carcinoma. Chemotherapy. 1986;32(6):521-9. PubMed PMID: 3802955.

583: Magin RL, Hunter JM, Niesman MR, Bark GA. Effect of vesicle size on the clearance, distribution, and tumor uptake of temperature-sensitive liposomes. Cancer Drug Deliv. 1986 Fall;3(4):223-37. PubMed PMID: 3567843.

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585: Ben-Efraim S, Shoval S, Ophir R. The difference between 5-fluorouracil and melphalan in their ability to promote antitumor immune response against MOPC-315 plasmacytoma. Cancer Immunol Immunother. 1986;22(1):43-8. PubMed PMID: 2939947.

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587: Furue H. [Drug interactions with anticancer agents]. Gan To Kagaku Ryoho. 1985 Dec;12(12):2231-6. Review. Japanese. PubMed PMID: 3907502.

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595: Gokhale SV, Ganu UK, Ambaye RY. Effects of anticancer drugs on folate disposition and excretion. J Postgrad Med. 1985 Jul;31(3):123-7. PubMed PMID: 4087212.

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603: Taguchi T. [Chemotherapy for recurrent breast carcinoma]. Gan To Kagaku Ryoho. 1985 Mar;12(3 Pt 1):439-47. Japanese. PubMed PMID: 4004279.

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