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Alkylating agent

Mebendazole + Chemotherapy for Brain Tumor

Phase 1 & 2

Recruiting

Led By Julie Krystal, MD

Research Sponsored by Julie Krystal

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 1 year of age and ≤ 21 years of age

Pilocytic Astrocytoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-years post-treatment

Awards & highlights

Study Summary

This trial will test the safety and efficacy of the drug mebendazole when used in combination with standard chemotherapy drugs, in particular brain tumors.

Who is the study for?

This trial is for children and young adults aged 1 to 21 with progressive low-grade or high-grade gliomas, including various types of astrocytoma. Participants must have adequate organ function and a life expectancy over 3 months. Pregnant individuals, those allergic to mebendazole or similar drugs, or unable to take oral medication due to vomiting are excluded.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of mebendazole combined with standard chemotherapy (vincristine, carboplatin, temozolomide) for low-grade gliomas and adds it to bevacizumab and irinotecan for high-grade gliomas. The goal is to see if this treatment can improve survival rates in pediatric brain tumor patients.See study design

What are the potential side effects?

Mebendazole may cause stomach pain, diarrhea, headache or dizziness; vincristine can lead to nerve damage; carboplatin might result in kidney issues; temozolomide could cause nausea; bevacizumab increases bleeding risk; irinotecan may trigger severe diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 1 and 21 years old.

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I have been diagnosed with Pilocytic Astrocytoma.

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I have a low-grade glioma that has come back, but I haven't failed treatment with the drugs in this study.

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I am between 1 and 21 years old.

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I have been diagnosed with a type of brain tumor called glioma.

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My MRI shows my brain tumor is growing or I have symptoms from a tumor in my optic pathway.

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I have a low-grade glioma that has come back but haven't failed treatment with the drugs in this study.

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I have a spinal cord or brainstem tumor confirmed by imaging.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-years post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mebendazole

Maximally tolerated dose of mebendazole in combination with vincristine, carboplatin, and temozolomide

Secondary outcome measures

Frequency of cerebrospinal fluid (CSF) dissemination in pilomyxoid astrocytoma

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

+2 more

Side effects data

From 2015 Phase 3 trial • 295 Patients • NCT02034162

Diarrhoea

100%

80%

60%

40%

20%

Study treatment Arm

OL Mebendazole 500 mg

Double-blind Placebo

Double-blind Mebendazole 500 mg

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low-grade GliomaExperimental Treatment4 Interventions

Patients on the low-grade arm will receive treatment with seven 10-week cycles of carboplatin, vincristine, temozolomide, and mebendazole.

Group II: High-grade Glioma/Pontine GliomaExperimental Treatment3 Interventions

Patients 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mebendazole

2019

Completed Phase 4

~4670

Vincristine

2003

Completed Phase 4

~2910

Carboplatin

2014

Completed Phase 3

~6670

Temozolomide

2010

Completed Phase 3

~1930

Bevacizumab

2013

Completed Phase 4

~5280

Irinotecan

2017

Completed Phase 4

~2680

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Julie KrystalLead Sponsor

Janssen PharmaceuticalsIndustry Sponsor

80 Previous Clinical Trials

205,035 Total Patients Enrolled

Julie Krystal, MDPrincipal Investigator - Northwell Health

Northwell Health

Media Library

Carboplatin (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT01837862 — Phase 1 & 2

Diffuse Intrinsic Pontine Glioma Research Study Groups: High-grade Glioma/Pontine Glioma, Low-grade Glioma

Diffuse Intrinsic Pontine Glioma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT01837862 — Phase 1 & 2

Carboplatin (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01837862 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are taking part in this healthcare investigation?

"Affirmative. According to the information on clinicaltrials.gov, this research project is actively seeking participants. It was initially posted in October 2013 and most recently updated April 5th 2022; currently looking for 36 subjects at one location."

Answered by AI

Can you shed some light on prior research projects utilizing Mebendazole?

"At present, 1556 trials are underway for Mebendazole. 409 of which have moved into the advanced Phase 3 testing stages. While Houston, Texas is a major hub for these kind of studies; 7735 other locations around the globe are running trails on this medication as well."

Answered by AI

What condition can Mebendazole typically alleviate?

"Mebendazole is widely used to treat the symptoms of non-Hodgkin's lymphoma, but can also be employed in cases of recurrent cervical cancer, refractory ewing sarcoma, and metastatic neoplasm."

Answered by AI

What objectives are the researchers hoping to accomplish with this investigation?

"The primary outcome of this clinical trial will be the maximally tolerated dose of mebendazole when combined with vincristine, carboplatin and temozolomide over a 12 week period. Secondary objectives include measuring frequencies of cerebrospinal fluid (CSF) dissemination in pilomyxoid astrocytomas, 3-year event-free survival (EFS) and overall survival (OS) for patients with low grade gliomas post surgical resection, as well as partial or complete response rate on MRI scans for those dealing with high grade glioma/pontine gliomata following"

Answered by AI

Is the cutoff for eligibility to participate in this research study 85 years of age or older?

"This clinical trial is accessible to individuals between 1 year and 21 years of age. Furthermore, there are 360 trials for people below 18 and 1981 trials available for those older than 65."

Answered by AI

Is enrolment in this trial still open?

"Affirmative. According to clinicaltrials.gov, this medical trial was initially posted on October 22nd 2013 and has been recently modified on April 5th 2022; the study looks for 36 participants at one particular centre."

Answered by AI

Does my profile qualify me to be a participant in this investigation?

"This clinical trial seeks 36 participants between the ages of one and 21 with a diagnosis of pilocytic astrocytoma, fibrillary astrocytoma, pilomyxoid astrocytoma, pleomorphic xanthoastrocytomas or other low-grade gliomas. Furthermore, they must not have previously failed therapy with any chemotherapeutic agents used in this study nor be children with optic pathway tumors that show clear evidence of progressive disease on MRI scans or present symptoms such as deteriorating vision, hypothalamic/pituitary dysfunction or precocious puberty. Lastly these conclusions need to be supported"

Answered by AI