Mebendazole for Pilocytic Astrocytoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cohen Children's Medical Center of New York, New Hyde Park, NY
Pilocytic Astrocytoma+14 More
Mebendazole - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas

See full description

Eligible Conditions

  • Pilocytic Astrocytoma
  • Pilomyxoid Astrocytoma
  • Glioblastoma Multiforme (GBM)
  • Gliosarcoma
  • Brain Stem Gliomas
  • Glioma, Astrocytic
  • Optic Nerve Glioma
  • DIPG
  • Diffuse Intrinsic Pontine Glioma
  • Pleomorphic Xantho-Astrocytoma
  • Anaplastic Astrocytoma (AA)
  • Low-grade Glioma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Pilocytic Astrocytoma

Study Objectives

This trial is evaluating whether Mebendazole will improve 2 primary outcomes and 5 secondary outcomes in patients with Pilocytic Astrocytoma. Measurement will happen over the course of Assessed after the 10 week Induction cycle.

3 years post-treatment
Frequency of cerebrospinal fluid (CSF) dissemination in pilomyxoid astrocytoma
3-years post-treatment
Partial or complete response rate on MRI of patients with high-grade gliomas/pontine gliomas
Partial or complete response rate on MRI of patients with low-grade gliomas
Survival of patients with high-grade gliomas
Survival of patients with low-grade gliomas
Week 10
Maximally tolerated dose of mebendazole in combination with vincristine, carboplatin, and temozolomide
Week 12
Maximally tolerated dose of mebendazole in combination with bevacizumab and irinotecan.

Trial Safety

Safety Progress

1 of 3

Other trials for Pilocytic Astrocytoma

Trial Design

2 Treatment Groups

High-grade Glioma/Pontine Glioma
1 of 2
Low-grade Glioma
1 of 2
Experimental Treatment

This trial requires 36 total participants across 2 different treatment groups

This trial involves 2 different treatments. Mebendazole is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

High-grade Glioma/Pontine GliomaPatients on the high-grade glioma/pontine glioma arm will receive treatment with twelve 28-day cycles of bevacizumab, irinotecan, and mebendazole. *High grade arm enrollment complete, no additional spots
Low-grade GliomaPatients on the low-grade arm will receive treatment with seven 10-week cycles of carboplatin, vincristine, temozolomide, and mebendazole.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine
FDA approved
Bevacizumab
FDA approved
Irinotecan
FDA approved
Mebendazole
FDA approved
Temozolomide
FDA approved
Carboplatin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3-years post-treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3-years post-treatment for reporting.

Closest Location

Cohen Children's Medical Center of New York - New Hyde Park, NY

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Pilocytic Astrocytoma or one of the other 14 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age > 1 year of age and ≤ 21 years of age
Diagnosis
Pilocytic Astrocytoma
Fibrillary Astrocytoma
Pilomyxoid Astrocytoma
Pleomorphic Xanthoastrocytoma
Other low grade astrocytomas
Children with optic pathway tumors must have evidence of progressive disease on MRI and/or symptoms of deteriorating vision or, progressive hypothalamic/pituitary dysfunction or, diencephalic syndrome or precocious puberty.
Patients with relapsed low-grade gliomas 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 used in this study.
Histology: Biopsy-proven

Patient Q&A Section

How many people get glioma a year in the United States?

"About 43,000 people would be diagnosed with a glioma in the United States each year. This is 14% of the population. The peak age for glioma to occur is age 60 years. There is also an increasing trend in glioma incidence (increasing rates) which has been seen in at least the past decade for men and women." - Anonymous Online Contributor

Unverified Answer

What causes glioma?

"The cause of glioma is still unknown, but in most cases, it is a consequence of either a genetic and/or exposure-related anomaly, with no single cause as yet identified. In many cases, glioma appears to be a consequence of a benign lesion, and a number of genetic lesions have been shown to cause a subset of cases. Gliomas may also develop de novo from a normal brain, which is termed "de novo" astrocytomas or "de novo" oligodendroglioma." - Anonymous Online Contributor

Unverified Answer

What is glioma?

"The pathogenesis of glioma has been investigated for at least two hundred years, yet there are still no definitive answers to the questions of the origin of the malignancy and the underlying mechanism(s) of progression to malignancy. Currently, the field of glioblastoma research is focused on identifying molecular genetic events crucial for gliomagenesis and the consequent development of novel therapeutic agents. Because many of these events were first detected through genetic studies of mammalian cell lines (e.g., NIH/3T3), the first priority for molecularly defined tumors is to determine whether they arise from these or other cell types." - Anonymous Online Contributor

Unverified Answer

What are the signs of glioma?

"In addition to the symptoms listed above, signs of cancer that may be present in patients with low-grade glioma include confusion, seizures and visual defects. Other signs that may be present include headaches, visual distortions, visual loss and aphasia. Patients with high-grade glioma may experience seizures and headache." - Anonymous Online Contributor

Unverified Answer

Can glioma be cured?

"Glioma cannot be cured by conventional medical treatments. The key to long-term treatment success is the combined approach of surgery, radiation and chemotherapy. At present, standard treatment cannot result in cure, but it can improve the quality of life of patients; the goal is to reduce the cancer load sufficiently to permit tumour resection with curative intent. It remains to be elucidated whether it is possible at some tumour sites, such as low-grade astrocytomas and glioblastomas, where surgery without post-operative radiotherapy is appropriate, to prevent tumour progression." - Anonymous Online Contributor

Unverified Answer

What are common treatments for glioma?

"Most cases of glioma are treated by surgery which is followed by radiation therapy. Chemotherapy is used to treat some recurrent glioma and can be administered before and after surgery because of its role in inhibiting tumor cells from regenerating." - Anonymous Online Contributor

Unverified Answer

What is mebendazole?

"Mebendazole does cross the blood-brain barrier and is active in animal models of human tumors with the IDH mutation but not in cells lacking that mutation. Findings from a recent study, the mouse glioma cell line expressing the IDH1 mutation was more sensitive to mibendazole." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in mebendazole for therapeutic use?

"Results from a recent clinical trial demonstrate that mebendazole is effective in the control of rat brainworm infestations and is very easy to use. Further trials would be desirable." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for glioma?

"For the past few decades of glioma diagnosis, 5 year survival has been more than 80%. However survival at 10 year is about 70% and this is expected to keep on decreasing with time and with advancements in the medical field. Currently there are no guidelines that are used to assess when medical treatment should be started for patients who survive a cancer diagnosis, but a few simple factors are taken into consideration when deciding medical treatment for the patient\n" - Anonymous Online Contributor

Unverified Answer

How quickly does glioma spread?

"There is a wide range of time to progression after surgery for newly diagnosed primary glioma. A substantial amount of residual disease remains in most patients, even some with high-grade, dedifferentiated, and grade-4 tumors. We observed that residual disease can be quite advanced even 12 months or more after surgery in patients with very low-grade glioma; therefore, it is imperative that patients are diagnosed with anaplastic low-grade gliomas to ensure their disease is adequately treated." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of mebendazole?

"Mycotic hypersensitivity reactions were encountered in about 9 out of 100 study patients. The dose adjustments were needed in patients with hypersensitivity. In the rest of the patients the dose was adjusted. Mild diarrhea and nausea was reported in the case of severe hypersensitivity. Mild to moderate skin reactions also occurred with the use of the drug. Skin irritation and rashes were reported with repeated use. The adverse effects were generally mild with close follow-up. The duration of treatment was about 11 - 56 days. Mycoses were observed in about 15 out of 100 patients who used the drug for some length of time. The lesions observed were mild and localised and the drug was withdrawn whenever they occurred." - Anonymous Online Contributor

Unverified Answer

Has mebendazole proven to be more effective than a placebo?

"In a recent study, findings demonstrate that mebendazole is an effective treatment for mild-to-moderate giardiasis, supporting the contention that this drug should be reconsidered for the treatment of mild-to-moderate cases of chronic giardiasis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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