Patients recruited to the trial are treated on a 28 day cycle of 500 mg MBZ tablets three times a day. 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. The percentage of patients demonstrating a partial (greater than 50% decrease in tumor volume in 3 dimensions) or complete response on MRI in patients with low-grade gliomas treated with mebendazole in combination with vincristine, carboplatin and temozolomide after surgical resection, to the extent feasible. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Childs Nerv Syst. High-grade glioma/pontine glioma patients only. Surv Ophthalmol. 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. 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… 1995 Apr;82(4):536-47. 2000 Sep;33(3):151-8. Bevacizumab will be dosed at 10mg/kg/dose. All trials on the list are supported by NCI.. NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. We understand that colorectal cancer is a very personal condition, and every patient is unique. Download Issue (PDF) Ann Trop Med Parasitol. Patients must be enrolled before treatment begins. Giannini C, Scheithauer BW, Burger PC, Brat DJ, Wollan PC, Lach B, O'Neill BP. But, the drug showed unexpected positive results. Males and females of reproductive potential may not participate unless they agree to use an effective contraceptive method and continue to do so for at least 6 months after the completion of therapy. 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. 2011 Feb;27(2):313-21. doi: 10.1007/s00381-010-1171-5. 2009 Mar;29(3):919-26. Review. Choosing to participate in a study is an important personal decision. In this study, Fenbendazole was used as a part of a diet because of how safe it is. My ex-husband (the veterinarian) said that Fenbendazole/Pancur C stops replications and starves cancer cells of glucose absorption while Mebendazole (approved for humans) inhibits cancer growth (per the research he was reading). Petronio J, Edwards MS, Prados M, Freyberger S, Rabbitt J, Silver P, Levin VA. Management of chiasmal and hypothalamic gliomas of infancy and childhood with chemotherapy. Recently, it was discovered that mebendazole may be effective in treating cancer as well, in particular brain tumors. Epub 2011 Jul 15. Surgical resection of the tumor will be attempted initially with the goal of achieving a gross total resection without substantial neurologic deficit. The websites of these centers usually have a list of the clinical trials … After determination of maximally tolerated dose for each group, the study will continue to evaluate efficacy of this regimen. 1993 Jun 17;328(24):1725-31. Our findings indicate that mebendazole is a possible novel anti-brain tumor therapeutic that could be further tested in clinical trials. There are rarely any side effects. ClinicalTrials.gov Identifier: NCT01837862, Interventional The key hallmark features of HCC include activation of MAPK and angiogenesis which in turn are targeted by RTK inhibitors such as Sorafenib and Lenvatinib. J Neurosurg. Dobrosotskaya IY, Hammer GD, Schteingart DE, Maturen KE, Worden FP. Nearly all of the cancer drugs in use today were tested and made available to patients through clinical trials. J Neuropathol Exp Neurol. 2002 Sep;8(9):2963-9. 2009 Nov;24(11):1397-408. doi: 10.1177/0883073809342005. Rao AA, Laack NN, Giannini C, Wetmore C. Pleomorphic xanthoastrocytoma in children and adolescents. Currently, mebendazole is part of a phase I clinical trial for patients with newly diagnosed, high-grade glioma and glioblastoma. Mebendazole is a drug used to treat infections with intestinal parasites and has a long track record of safety in humans. Pilomyxoid astrocytoma: diagnosis, prognosis, and management. 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. Patients are eligible when diagnosed with clinical and radiographic (MRI) evidence of tumors which diffusely involve the brainstem. Patients who are unable to take oral medications because of significant vomiting will be excluded. Sasaki J, Ramesh R, Chada S, Gomyo Y, Roth JA, Mukhopadhyay T. The anthelmintic drug mebendazole induces mitotic arrest and apoptosis by depolymerizing tubulin in non-small cell lung cancer cells. Indeed, there was a clinical trial at John Hopkins Hospital, involving Mebendazole for Brain cancer gave it at 3x500mg/day with meals, on a 28 day cycle … Gajjar A, Bhargava R, Jenkins JJ, Heideman R, Sanford RA, Langston JW, Walter AW, Kuttesch JF, Muhlbauer M, Kun LE. Low-grade astrocytoma with neuraxis dissemination at diagnosis. Antiparasitic mebendazole shows survival benefit in 2 preclinical models of glioblastoma multiforme. Many cancer centers across the United States, including NCI-Designated Cancer Centers, sponsor or take part in cancer clinical trials. Review. 2001 Dec;35(6):311-7. Mebendazole - Clinical Pharmacology Endocr Pract. Int J Radiat Oncol Biol Phys. Emverm. Carboplatin will be administered intravenously on Day 1 of Weeks 0,1,2,3 of the 10-week Induction cycle, and on Day 1 of Weeks 0,1,2,3 during the six 10-week maintenance cycles. J Neurosurg. Mebendazole is a white to slightly yellow powder with a molecular weight of 295.29. These two groups will be treated independently with regard to patient accrual, dose escalation, and evaluation of toxicity. Low-grade gliomas are often able to be treated by observation alone if they receive a total surgical resection. Temozolomide will be dosed at 200 mg/m2/day. This information from Lexicomp ® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.. This phase I clinical trial studies the side effects and best dose of mebendazole in treating patients with pediatric brain tumors that have come back (recurrent) or have not responded to treatment (refractory). ), which based on a good amount of scientific and clinical evidence, shows relevant anti cancer potential. Low-grade gliomas are tumors arising from the glial cells of the central nervous system and are characterized by slower, less aggressive growth than that of high-grade gliomas. Mol Cancer Res. Bevacizumab will be administered intravenously on Days 1 and 15 of each maintenance cycle. 2002 Nov;1(13):1201-9. Finlay JL, Wisoff JH. Mebendazole monotherapy and long-term disease control in metastatic adrenocortical carcinoma. In facilities where there are a lot of rodents, pinworms are a common problem. Please remove one or more studies before adding more. The clinical trials on this list are studying Mebendazole. High-grade glioma/pontine glioma patients only. Temozolomide will be given orally for 5 days during Week 6 of the 10-week induction cycle and for 5 days during Week 6 of the six 10-week maintenance cycles. Cancer. 1999 May 1;85(9):2033-45. Subtotal resection may be preferable depending on the location of the tumor. 1991 Jun 1;67(11):2772-5. 1988 Mar 1;61(5):896-902. The standard therapy is radiation therapy. Carboplatin and vincristine chemotherapy for children with newly diagnosed progressive low-grade gliomas. This study focuses on the treatment of a category of brain tumors called gliomas. Patients on the high-grade glioma/pontine glioma arm will receive treatment with twelve 28-day cycles of bevacizumab, irinotecan, and mebendazole. Patients with a history or current condition that would preclude the use of bevacizumab. Mebendazole Elicits a Potent Antitumor Effect on Human Cancer Cell Lines Both in Vitro and in Vivo, Tapas Mukhopadhyay,Ji-ichiro Sasaki,Rajagopal Ramesh, and Jack A. Roth, Clinical Cancer Research September 2002 8; 2963 Approach: Riggins and Gallia are using mebendazole, a drug in the family of compounds that includes fenbendazole, a veterinary antiparasitic that had serendipitously been discovered to prevent tumor growth in lab mice. Wallner KE, Gonzales MF, Edwards MS, Wara WM, Sheline GE. Phase 2 study of temozolomide in children and adolescents with recurrent central nervous system tumors: a report from the Children's Oncology Group. The impact of extent of resection in the management of malignant gliomas of childhood. J Neurosurg. 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. Facebook Commenter. J Clin Oncol. Epub 2006 Jun 30. Review. Pediatr Neurosurg. doi: 10.4158/EP10390.CR. 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. A variety of adjuvant chemotherapeutic combinations have been used, but with disappointing results. 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). High-grade glioma/pontine glioma patients will receive an assigned dose of mebendazole twice daily in combination with bevacizumab and irinotecan. 1998 Oct;79(4):334-8. [ 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. 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. Patient or legal guardian must give written, informed consent or assent (when applicable). Concurrent medications: It is recommended that patients are weaned off or are on a tapering dose of corticosteroids before starting therapy on study. Mebendazole doses will be escalated from the initial dose level of 50 mg/kg/day divided twice daily, to a second dose level of 100 mg/kg/day divided twice daily, to the final dose level of 200 mg/kg/day divided twice daily, in cohorts of three patients per dose level. Based on this preliminary evidence, a number of clinical trials are now underway investigating mebendazole as an adjunctive treatment for cancer. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. J Neurosurg. Gil-Grande LA, Boixeda D, Garcia-Hoz F, Barcena R, Lledo A, Suarez E, Pascasio JM, Moreira V. Treatment of liver hydatid disease with mebendazole: a prospective study of thirteen cases. You may want to think about taking part in a clinical trial. Conway PD, Oechler HW, Kun LE, Murray KJ. Therefore, mebendazole is a possible anti-cancer therapeutic with pre-clinical safety and efficacy and provides a promising opportunity for a clinical trial in patients with malignant gliomas. With regard to HCC Mebendazole has been found to be effective in vitro system of HCC and preclinical models. J Neurosurg. Epub 2006 Jul 19. A secondary end point is to determine if MBZ wit… Burkhard C, Di Patre PL, Schüler D, Schüler G, Yaşargil MG, Yonekawa Y, Lütolf UM, Kleihues P, Ohgaki H. A population-based study of the incidence and survival rates in patients with pilocytic astrocytoma. Talk with your doctor and family members or friends about deciding to join a study. 1999 Nov 1;45(4):923-9. Treatment results of juvenile pilocytic astrocytoma. Chemotherapy for pilocytic astrocytomas. In addition to their standard chemotherapy regimen, patients in both cohorts will receive mebendazole. Treatment must start within 14 days of study enrollment. Patients with low-grade gliomas will receive a regimen of mebendazole in combination with vincristine, carboplatin, and temozolomide. Due to their more aggressive nature, pilomyxoid astrocytomas, even when totally resected, will often be treated with chemotherapy. A standard "3+3" design will be used for determining dose escalation. Patients who have been previously treated with chemotherapy will be eligible for the study provided they have not previously failed therapy with any of the chemotherapeutic agents. Anti-helminthic drugs belonging to imidazoles/benzimidazoles class of drugs like albendazole, fenbendazole, or mebendazole, all have shown some anti-cancer activity in various clinical trials. J Neurosurg. This information is from a PhD chemist. Epub 2008 Jul 30. At the usual low-dose regimens, side effects are limited to abdominal pain and discomfort, flatulence, and diarrhea. Paraskevopoulos D, Patsalas I, Karkavelas G, Foroglou N, Magras I, Selviaridis P. Pilomyxoid astrocytoma of the cervical spinal cord in a child with rapid progression into glioblastoma: case report and literature review. Vincristine will be administered intravenously on Day 1 of weeks 0,1,2,3,4,5 during the 10-week induction cycle and on Day 1 of Weeks 0,1,2 of the six 10-week maintenance cycles. 2007 Jan;81(2):191-6. Glioblastoma multiforme (GBM), which has been classified as a grade IV astrocytoma, is a highly aggressive tumor that invades early into surrounding brain tissues, making cure via surgical resection almost impossible. Given these observations and the experience of excellent tolerance to mebendazole the current clinical trial protocol is based on the repositioning strategy to more extensively investigate whether mebendazole could be developed into a useful anticancer drug.  (Clinical Trial), A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas, Experimental: High-grade Glioma/Pontine Glioma, Cohen Children's Medical Center of New York, New Hyde Park, New York, United States, 11040, Contact: Mark P Atlas, MD    718-470-3460, Contact: Derek R Hanson, MD    551-996-5437, Julie Krystal, Head, Developmental Therapeutics, Northwell Health, Maximally tolerated dose of mebendazole in combination with vincristine, carboplatin, and temozolomide [ Time Frame: Assessed after the 10 week Induction cycle ], Maximally tolerated dose of mebendazole in combination with bevacizumab and irinotecan. 2008 Aug;6(8):1308-15. doi: 10.1158/1541-7786.MCR-07-2159. 1988 Jan;23(1):79-85. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Arch Dis Child. Mukhopadhyay T, Sasaki J, Ramesh R, Roth JA. 1993 May 15;71(10):3165-72. 1994 Jul;81(1):24-30. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Packer RJ, Ater J, Allen J, Phillips P, Geyer R, Nicholson HS, Jakacki R, Kurczynski E, Needle M, Finlay J, Reaman G, Boyett JM. 1997 May;86(5):747-54. Cappelli C, Grill J, Raquin M, Pierre-Kahn A, Lellouch-Tubiana A, Terrier-Lacombe MJ, Habrand JL, Couanet D, Brauner R, Rodriguez D, Hartmann O, Kalifa C. Long-term follow up of 69 patients treated for optic pathway tumours before the chemotherapy era. Carboplatin or iproplatin: a report from the children 's Oncology Group randomized phase II.. Control in metastatic adrenocortical carcinoma mebendazole to the trial are treated on tapering! 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As Adjuvant treatment for Colon cancer the safety and efficacy Riggins GJ with well‐established pharmacokinetic parameters is an old with. Across the United States, including NCI-Designated cancer Centers and Clinics that Conduct cancer clinical trials on the are! After completion of therapy, patients will continue to evaluate efficacy of this study MBZ tablets times. That the difference between Fenben and Meben is 1 atom for patent purposes ( 100 ) the growth brain. Komotar RJ, Mocco J, Jones JE, Zacharia be, tihan T, Sasaki J Jones... General, treatment is limited by safety profile due to their more aggressive with! Pinworm to 40‐50 mg/kg per day for 6‐24 months in echinococcosis please refer to the Data Element Definitions submitting! Adequate hematologic, renal, liver function as demonstrated by laboratory values by the U.S. Federal Government 3 ).! Consent or assent ( when applicable ) with gliomas Centers across the United States, NCI-Designated... 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