Author contributions Optic pathway gliomas and diffuse intrinsic pontine gliomas may remain unresected. The current first-line treatment at our institution for these low-grade gliomas involves a three-drug chemotherapy regimen of vincristine, carboplatin, and temozolomide. ), which based on a good amount of scientific and clinical evidence, shows relevant anti cancer potential. 2005 Jun 15;18(6A):E7. J Neurosurg. 1993 May 15;71(10):3165-72. N Engl J Med. Cancer. Tsugu H, Oshiro S, Yanai F, Komatsu F, Abe H, Fukushima T, Nomura Y, Matsumoto S, Nabeshima K, Takano K, Utsunomiya H. Management of pilomyxoid astrocytomas: our experience. This study focuses on the treatment of a category of brain tumors called gliomas. 1995 Jul;83(1):67-71. Standard of care currently consists of radiotherapy combined with chemotherapy of DNA-alkylating/methylating temozolomide (TMZ), which has increased the mean duration of patient survival to 15 months.1 Currently, only 10% of patients with GBM, including all post-treatment living con… Irinotecan will be administered intravenously on Days 1 and 15 of each maintenance cycle. [ Time Frame: Assessed after the first 3 maintenance cycles (12 weeks) ], Survival of patients with low-grade gliomas [ Time Frame: 3-years post-treatment ], Survival of patients with high-grade gliomas [ Time Frame: 3-years post-treatment ], Frequency of cerebrospinal fluid (CSF) dissemination in pilomyxoid astrocytoma [ Time Frame: 3 years post-treatment ], Partial or complete response rate on MRI of patients with high-grade gliomas/pontine gliomas [ Time Frame: 3-years post-treatment ], Partial or complete response rate on MRI of patients with low-grade gliomas [ Time Frame: 3-years post-treatment ], Age > 1 year of age and ≤ 21 years of age. Phase 2 study of temozolomide in children and adolescents with recurrent central nervous system tumors: a report from the Children's Oncology Group. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837862. All trials on the list are supported by NCI. Clin Cancer Res. Due to their more aggressive nature, pilomyxoid astrocytomas, even when totally resected, will often be treated with chemotherapy. 2008 Aug;6(8):1308-15. doi: 10.1158/1541-7786.MCR-07-2159. Opocher E, Kremer LC, Da Dalt L, van de Wetering MD, Viscardi E, Caron HN, Perilongo G. Prognostic factors for progression of childhood optic pathway glioma: a systematic review. Friedman HS, Krischer JP, Burger P, Oakes WJ, Hockenberger B, Weiner MD, Falletta JM, Norris D, Ragab AH, Mahoney DH Jr, et al. The part that is effective against cancer is effective in both. Currently, mebendazole is part of a phase I clinical trial for patients with newly diagnosed, high-grade glioma and glioblastoma. All clinical and laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated in the eligibility section. During the first three maintenance therapy cycles (12 weeks), patients will be assessed for dose-limiting toxicity that is beyond the expected toxicity from the standard regimen of bevacizumab and irinotecan alone. J Neuropathol Exp Neurol. 1999 Nov 1;45(4):923-9. Mol Cancer Ther. 1998 Jul;89(1):52-9. Clinical trials look at new ways to prevent, detect, or treat disease. Brand Names: Canada. For general information, Learn About Clinical Studies. 3-year event-free survival (EFS) and overall survival (OS) of patients with high-grade gliomas treated with bevacizumab, irinotecan, and mebendazole in combination following surgical resection to the extent feasible and local irradiation. Clinical trials are scientific studies in which new treatments (drugs, diagnostic procedures and other therapies) are tested in patients to determine if they are safe and effective. Int J Radiat Oncol Biol Phys. Concurrent medications: It is recommended that patients are weaned off or are on a tapering dose of corticosteroids before starting therapy on study. At the usual low-dose regimens, side effects are limited to abdominal pain and discomfort, flatulence, and diarrhea. Recently, it was discovered that mebendazole may be effective in treating cancer as well, in particular brain tumors. Although the original clinical approval for fenbendazole was for intestinal parasites and not for cancer, the drug has already gone through human clinical trials and so all of the clinical trial work related to toxicity has already been done and febendazole has been … Brand Names: US. This is a study to determine the safety and efficacy of the drug, mebendazole, when used in combination with standard chemotherapy drugs for the treatment of pediatric brain tumors. Mebendazole is a drug used to treat infections with intestinal parasites and has a long track record of safety in humans. Janss AJ, Grundy R, Cnaan A, Savino PJ, Packer RJ, Zackai EH, Goldwein JW, Sutton LN, Radcliffe J, Molloy PT, et al. Bauman G, Lote K, Larson D, Stalpers L, Leighton C, Fisher B, Wara W, MacDonald D, Stitt L, Cairncross JG. Packer RJ, Sutton LN, Bilaniuk LT, Radcliffe J, Rosenstock JG, Siegel KR, Bunin GR, Savino PJ, Bruce DA, Schut L. Treatment of chiasmatic/hypothalamic gliomas of childhood with chemotherapy: an update. Wallner KE, Gonzales MF, Edwards MS, Wara WM, Sheline GE. Low-grade glioma patients will receive an assigned dose of mebendazole twice daily in combination with vincristine, carboplatin and temozolomide. Pediatric low-grade gliomas. Ceppa EP, Bouffet E, Griebel R, Robinson C, Tihan T. The pilomyxoid astrocytoma and its relationship to pilocytic astrocytoma: report of a case and a critical review of the entity. Treatment must start within 14 days of study enrollment. Low-grade glioma patients will not receive radiation therapy. Mebendazole induces apoptosis via Bcl-2 inactivation in chemoresistant melanoma cells. J Child Neurol. J Clin Oncol. Gajjar A, Bhargava R, Jenkins JJ, Heideman R, Sanford RA, Langston JW, Walter AW, Kuttesch JF, Muhlbauer M, Kun LE. Mebendazole will be prescribed according to the particular dose cohort for each patient (50 mg/kg/day, 100 mg/kg/day, or 200 mg/kg/day). Wisoff JH, Boyett JM, Berger MS, Brant C, Li H, Yates AJ, McGuire-Cullen P, Turski PA, Sutton LN, Allen JC, Packer RJ, Finlay JL. Doudican N, Rodriguez A, Osman I, Orlow SJ. Packer RJ, Ater J, Allen J, Phillips P, Geyer R, Nicholson HS, Jakacki R, Kurczynski E, Needle M, Finlay J, Reaman G, Boyett JM. Mebendazole - Clinical Pharmacology The study patients will be divided into two groups (low-grade glioma and high-grade/pontine glioma) for the purpose of determining the maximally tolerated dose of mebendazole. Gajjar A, Sanford RA, Heideman R, Jenkins JJ, Walter A, Li Y, Langston JW, Muhlbauer M, Boyett JM, Kun LE. Identification of selective therapeutic agents for metastatic prostate cancer by phenotype-based screening http://www.dtic.mil/dtic/tr/fulltext/u2/a545657.pdf Pretreatment factors predict overall survival for patients with low-grade glioma: a recursive partitioning analysis. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. To test the effects of the drug on cancer cells, researchers used xenografts. Similarly, the anti-malarial compound chloroquine showed surprising properties in combating cancer and tumor growth in a series of experiments led by a group at the University of Kentucky. We understand that colorectal cancer is a very personal condition, and every patient is unique. Mebendazole is a drug used to treat infections with intestinal parasites and has a long track record of safety in humans. 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