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NCT01837862 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas
A Phase 1 study of Glioblastoma Multiforme and Gliosarcoma, sponsored by Julie Krystal.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01837862 is a Phase 1 study of Glioblastoma Multiforme and Gliosarcoma that has completed, run by Julie Krystal. The registered enrollment target is 36 participants, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01837862, a Phase 1 study of Glioblastoma Multiforme and Gliosarcoma, has completed, sponsored by Julie Krystal.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
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. Recently, it was discovered that mebendazole may be effective in treating cancer as well, in particular brain tumors. Studies using both cell cultures and mouse models demonstrated that mebendazole was effective in decreasing the growth of brain tumor cells. This study focuses on the treatment of a category of brain tumors called gliomas. 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. Some low-grade gliomas have a more aggressive biology and an increased likelihood of resistance or recurrence. Low-grade gliomas are often able to be treated by observation alone if they receive a total surgical resection. However, tumors which are only partially resected and continue to grow or cause symptoms, or those which recur following total resection require additional treatment, such as chemotherapy. Due to their more aggressive nature, pilomyxoid astrocytomas, even when totally resected, will often be treated with chemotherapy. The current first-line treatment at our institution for these low-grade gliomas involves a three-drug chemotherapy regimen of vincristine, carboplatin, and temozolomide. However, based on our data from our own historical controls, over 50% of patients with pilomyxoid astrocytomas will continue to have disease progression while on this treatment. We believe that mebendazole in combination with vincristine, carboplatin, and temozolomide may provide an additional therapeutic benefit with increased progression-free and overall survival for low-grade glioma patients, particularly for those with pilomyxoid astrocytomas. High grade
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Carboplatin
- DRUG Temozolomide
- DRUG Vincristine
- DRUG Mebendazole
Study Locations (1)
New York
- Cohen Children's Medical Center of New York - New Hyde Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-10-22 |
| Est. Completion | 2024-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01837862
The ClinicalTrials.gov registry entry for NCT01837862 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (62% lower). The listed sponsor is Julie Krystal, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 5 interventions - of which Bevacizumab is the first listed.
NCT01837862 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01837862 about?
NCT01837862 is a clinical study titled "A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas". 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 huma...
What is the current status of trial NCT01837862?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2013-10-22. Estimated completion is 2024-04.
What conditions does trial NCT01837862 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Gliosarcoma, Anaplastic Astrocytoma, Diffuse Intrinsic Pontine Glioma, Pilocytic Astrocytoma.
What interventions are being tested in trial NCT01837862?
The interventions under investigation include: Bevacizumab (DRUG), Carboplatin (DRUG), Temozolomide (DRUG), Vincristine (DRUG), Mebendazole (DRUG).
Who is sponsoring clinical trial NCT01837862?
This trial is sponsored by Julie Krystal, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01837862 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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