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Phase I Study of Mebendazole Therapy for Recurrent/Progressive Pediatric Brain Tumors

NCT02644291 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-06-23

No results posted yet for this study

Summary

This is a safety (Phase 1) trial using mebendazole for recurrent pediatric brain cancers that include medulloblastoma and high grade glioma, that are no longing responding to standard therapies. The drug mebendazole is an oral drug in a chewable 500 mg orange flavored tablet. It is already approved to treat parasitic infections. The purpose of this study is to determine the safety and side effects for increasing doses of mebendazole, followed by the treatment of an additional 12 patients at the best tolerated dose.

Conditions

  • Medulloblastoma
  • Astrocytoma, Grade III
  • Glioblastoma
  • Anaplastic Astrocytoma
  • Brain Stem Neoplasms, Malignant
  • Oligodendroblastoma
  • Anaplastic Oligodendroglioma
  • Malignant Glioma

Interventions

DRUG

Mebendazole

chewable mebendazole tablets that can also be crushed and mixed with food or drink to be taken daily with meals

Sponsors & Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Kenneth J Cohen, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2022-06-09
Completion
2022-06-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02644291 on ClinicalTrials.gov