Mebendazole in Newly Diagnosed High-Grade Glioma Patients Receiving Temozolomide

NCT01729260 | Completed Phase 1 DMC

• 2 other identifiers: J1194NA_00049848
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find the highest dose of mebendazole (MBZ) that can be safely given to people with malignant brain tumors in combination with the current standard of care (temozolomide) without causing severe side effects. We also want to find out if MBZ can slow the growth of the brain tumor. The study doctors have found that MBZ is effective against malignant brain tumors in the laboratory and animal models of brain tumors.

Conditions

Newly Diagnosed High-Grade Glioma

Keywords

Glioblastoma; mebendazole; temozolomide

Outcome Measures

Primary Outcomes (1)

• maximum tolerated dose (MTD) of mebendazole

  To determine the maximum tolerated dose (MTD) of mebendazole in combination with temozolomide (TMZ) given after surgery and the standard radiation and TMZ treatment in patients with newly diagnosed malignant gliomas.

  8 months

Secondary Outcomes (1)

• Overall Survival

  10 years

Study Arms (1)

Mebendazole

EXPERIMENTAL

All study participants will receive study drug; Mebendazole.

Drug: Mebendazole

Interventions

Mebendazole DRUG

The mebendazole will be given by mouth three times every day on a 28 day cycle. it's in the form of 500 mg chewable tablets, to be taken with meals.

Also known as: Brand name: Vermox

Mebendazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed newly diagnosed high-grade glioma(WHO Grade III or IV)
• Age ≥18 years
• Karnofsky Performance Score (KPS) ≥ 60%
• Life expectancy greater than 12 weeks
• Patients must have adequate organ and marrow function
• Completed \>80% of the prescribed radiation therapy and concurrent temozolomide according to the Stupp regimen without grade 3 or 4 hematologic toxicity
• Patients may have received Gliadel during surgery
• Ability to swallow pills and keep medication record
• women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation.
• Ability to understand and willingness to sign a written informed consent document
• Be able to comply with treatment plan, study procedures and follow-up examinations

You may not qualify if:

• Patients must not have received prior therapy other than standard chemoradiation according to Stupp et al and Gliadel.
• Patients may not be receiving any other investigational agents while on study
• Patients who have known allergy to mebendazole or benzimidazole
• Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for a parasitic infection
• Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapy
• Patients who have taken any benzimidazole (ABZ, flubendazole, thiabendazole, fenbendazole, triclabendazole, etc.) within the last 3 months
• Patients who are taking any anti-convulsant medication that interferes with the cytochrome P450 pathway (e.g. phenytoin, phenobarbital, carbamazepine, etc.)
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, chronic hepatitis, acute hepatitis, or psychiatric illness/social situation that would limit compliance with study requirements
• Pregnant women are excluded
• Patients with human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C positive; or with a history of chronic active hepatitis or cirrhosis
• Patients with a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product administration or may interfere with the interpretation of the results
• Patients who are not available for follow-up assessments or unable to comply with study requirements

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Accelerate Brain Cancer Cure: collaborator

Study Sites (1)

The Johs Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Mebendazole

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gary Gallia, MD

  Johns Hopkins University School of Medicine, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 20, 2012
• Study Start: April 4, 2013
• Primary Completion: September 1, 2016
• Study Completion: April 16, 2021
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

US (1)