Phase I Study of Mebendazole for Treating Brain Tumors in Children
Sponsor: Julie Krystal
ClinicalTrials ID:NCT01837862
This study is testing the safety and effectiveness of adding the drug mebendazole to standard chemotherapy for treating brain tumors in children. Mebendazole is usually used to treat parasitic infections but may also help fight brain tumors.
Patient Parameters
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Program Overview
This study aims to find out if mebendazole, a drug typically used for treating parasitic infections, can be safely and effectively combined with standard chemotherapy drugs to treat brain tumors in children. The focus is on a type of brain tumor called gliomas, which can be either low-grade (less aggressive) or high-grade (more aggressive). For low-grade gliomas, mebendazole will be combined with vincristine, carboplatin, and temozolomide. For high-grade gliomas, it will be combined with bevacizumab and irinotecan. The study will determine the best dose of mebendazole and evaluate its impact on tumor growth and patient survival.
Description
This study involves using mebendazole along with standard chemotherapy drugs to treat children with brain tumors called gliomas. For low-grade gliomas, the treatment includes mebendazole with vincristine, carboplatin, and temozolomide. For high-grade gliomas, the treatment includes mebendazole with bevacizumab and irinotecan. The goal is to remove as much of the tumor as possible through surgery, but some tumors may not be fully removable due to their location. Patients with high-grade gliomas will receive radiation therapy before starting the study treatment. The study will determine the safest and most effective dose of mebendazole and monitor its effects on tumor growth and patient health. Patients will undergo regular MRI scans to track tumor changes and overall survival.
Eligibility Criteria
Inclusion Criteria
- Children aged 1 to 21 years.
- Diagnosed with specific types of brain tumors, such as low-grade gliomas (e.g., pilocytic astrocytoma) or high-grade gliomas (e.g., glioblastoma).
- Must start treatment within 14 days of joining the study.
- Must have adequate blood, kidney, and liver function.
- Women of childbearing age must have a negative pregnancy test before starting treatment.
- Must have a life expectancy of at least 3 months.
- Must be able to take oral medications.
- Must provide written consent to participate.
- Recent mothers must agree not to breastfeed during the study.
Exclusion Criteria
- Children under 1 year or over 21 years.
- Allergic to mebendazole or similar drugs.
- Have had severe side effects from mebendazole or similar drugs in the past.
- Taking metronidazole and cannot switch to another antibiotic before starting the study.
- Pregnant or breastfeeding women.
- Unable to take oral medications due to severe vomiting.
- For low-grade glioma group: Previously failed treatment with vincristine, carboplatin, or temozolomide.
- For high-grade glioma group: Previously failed treatment with bevacizumab or irinotecan, or tumor progression after radiation therapy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cohen Children's Medical Center of New York | 11040 | New Hyde Park | New York |
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