A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas

NCT01837862 | Completed Phase 1 DMC

• 1 other identifier: CCMC1411
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 gliomas are more aggressive tumors with poor prognoses. The standard therapy is radiation therapy. A variety of adjuvant chemotherapeutic combinations have been used, but with disappointing results. For high-grade gliomas this study will add mebendazole to the established combination of bevacizumab and irinotecan to determine this combinations safety and efficacy

Conditions

Pilomyxoid Astrocytoma; Pilocytic Astrocytoma; Glioma, Astrocytic; Optic Nerve Glioma; Pleomorphic Xanthoastrocytoma; Glioblastoma Multiforme; Anaplastic Astrocytoma; Gliosarcoma; Diffuse Intrinsic Pontine Glioma; DIPG; Low-grade Glioma; Brainstem Glioma

Keywords

pilomyxoid astrocytoma; Pilocytic Astrocytoma; Glioma; Optic Nerve Glioma; mebendazole; Pleomorphic Xanthoastrocytoma; glioblastoma multiforme; anaplastic astrocytoma; gliosarcoma; diffuse intrinsic pontine glioma; DIPG; low-grade glioma; high-grade glioma; brainstem glioma; pediatric

Outcome Measures

Primary Outcomes (2)

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

  Low-grade glioma patients will receive an assigned dose of mebendazole twice daily in combination with vincristine, carboplatin and temozolomide. During a 10 week induction period, patients will be assessed for dose-limiting toxicity that is beyond the expected toxicity from the standard regimen of vincristine, carboplatin, and temozolomide alone. This outcome measure will use a standard 3+3 design to dose-escalate mebendazole in three dose cohorts of 50 mg/kg/day, 100 mg/kg/day, and 200 mg/kg/day.

  Assessed after the 10 week Induction cycle

• Maximally tolerated dose of mebendazole in combination with bevacizumab and irinotecan.

  High-grade glioma/pontine glioma patients will receive an assigned dose of mebendazole twice daily in combination with bevacizumab and irinotecan. During the first three maintenance therapy cycles (12 weeks), patients will be assessed for dose-limiting toxicity that is beyond the expected toxicity from the standard regimen of bevacizumab and irinotecan alone. This outcome measure will use a standard 3+3 design to dose-escalate mebendazole in three dose cohorts of 50 mg/kg/day, 100 mg/kg/day, and 200 mg/kg/day.

  Assessed after the first 3 maintenance cycles (12 weeks)

Secondary Outcomes (5)

• Survival of patients with low-grade gliomas

  3-years post-treatment

• Survival of patients with high-grade gliomas

  3-years post-treatment

• Frequency of cerebrospinal fluid (CSF) dissemination in pilomyxoid astrocytoma

  3 years post-treatment

• Partial or complete response rate on MRI of patients with high-grade gliomas/pontine gliomas

  3-years post-treatment

• Partial or complete response rate on MRI of patients with low-grade gliomas

  3-years post-treatment

Study Arms (2)

Low-grade Glioma

EXPERIMENTAL

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

Drug: Mebendazole; Drug: Vincristine; Drug: Carboplatin; Drug: Temozolomide

High-grade Glioma/Pontine Glioma

EXPERIMENTAL

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

Drug: Mebendazole; Drug: Bevacizumab; Drug: Irinotecan

Interventions

Mebendazole DRUG

Mebendazole will be given orally twice daily for over the course of treatment (70 weeks for low-grade glioma patients, 48 weeks for high-grade glioma/pontine glioma patients). Mebendazole will be prescribed according to the particular dose cohort for each patient (50 mg/kg/day, 100 mg/kg/day, or 200 mg/kg/day).

Also known as: Vermox

High-grade Glioma/Pontine Glioma; Low-grade Glioma

Vincristine DRUG

Low-grade glioma patients only. Vincristine will be dosed as per the following: For patients \< 12kg: 0.05 mg/kg; for patient \> 12kg: 1.5mg/m2 (maximal dose 2.0 mg). Vincristine will be administered intravenously on Day 1 of weeks 0,1,2,3,4,5 during the 10-week induction cycle and on Day 1 of Weeks 0,1,2 of the six 10-week maintenance cycles.

Also known as: Oncovin

Low-grade Glioma

Carboplatin DRUG

Low-grade glioma patients only. Carboplatin will be dosed at 175 mg/m2. Carboplatin will be administered intravenously on Day 1 of Weeks 0,1,2,3 of the 10-week Induction cycle, and on Day 1 of Weeks 0,1,2,3 during the six 10-week maintenance cycles.

Also known as: Paraplatin

Low-grade Glioma

Temozolomide DRUG

Low-grade glioma patients only. Temozolomide will be dosed at 200 mg/m2/day. Temozolomide will be given orally for 5 days during Week 6 of the 10-week induction cycle and for 5 days during Week 6 of the six 10-week maintenance cycles.

Also known as: Temodar

Low-grade Glioma

Bevacizumab DRUG

High-grade glioma/pontine glioma patients only. Bevacizumab will be dosed at 10mg/kg/dose. Bevacizumab will be administered intravenously on Days 1 and 15 of each maintenance cycle.

Also known as: Avastin

High-grade Glioma/Pontine Glioma

Irinotecan DRUG

High-grade glioma/pontine glioma patients only. Irinotecan will be administered at doses 125 mg/m2, 150 mg/m2, 250 mg/m2, or 300 mg/m2, depending on patient tolerance and concomitant enzyme-inducing anti-epileptic medication use. Irinotecan will be administered intravenously on Days 1 and 15 of each maintenance cycle.

Also known as: CPT-11, Camptosar

High-grade Glioma/Pontine Glioma

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age \> 1 year of age and ≤ 21 years of age
• Diagnosis
• Group A - Low-grade Glioma Group:
• Histology: Biopsy-proven:
• Pilocytic Astrocytoma
• Fibrillary Astrocytoma
• Pilomyxoid Astrocytoma
• Pleomorphic Xanthoastrocytoma
• Other low grade astrocytomas
• Children with optic pathway tumors must have evidence of progressive disease on MRI and/or symptoms of deteriorating vision or, progressive hypothalamic/pituitary dysfunction or, diencephalic syndrome or precocious puberty.
• Patients with relapsed low-grade gliomas who have been previously treated with chemotherapy will be eligible for the study provided they have not previously failed therapy with any of the chemotherapeutic agents used in this study.
• Group B - High-grade Glioma/Pontine Glioma Group:
• Histology: Biopsy-proven
• Anaplastic astrocytoma
• Glioblastoma multiforme

You may not qualify if:

• Age \< 1 year or \> 21 years
• Patients who have known allergy to mebendazole or benzimidazole class drugs.
• 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.
• Pregnant female patients are not eligible for this study. Pregnancy tests with a negative result must be obtained in all post-menarchal females.
• Lactating females must agree they will not breastfeed a child while on this study.
• Males and females of reproductive potential may not participate unless they agree to use an effective contraceptive method and continue to do so for at least 6 months after the completion of therapy.
• Patients who are unable to take oral medications because of significant vomiting will be excluded.
• Group A - Low-grade Glioma Group ONLY:
• Patients who have failed prior chemotherapy with vincristine, carboplatin, or temozolomide for this tumor are excluded.
• Patients with Neurofibromatosis Type 1
• Group B - High-grade Glioma/Pontine Glioma Group ONLY:
• Patients who failed prior chemotherapy with bevacizumab or irinotecan for this tumor are excluded.
• Patients who progressed on or within 12 weeks after completion of radiotherapy are excluded.
• Patients with a history or current condition that would preclude the use of bevacizumab

Sponsors & Collaborators

• Julie Krystal: lead
• Janssen Pharmaceuticals: collaborator

Study Sites (1)

Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

Location

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MeSH Terms

Conditions

Astrocytoma; Optic Nerve Glioma; Glioblastoma; Gliosarcoma; Diffuse Intrinsic Pontine Glioma; Glioma

Interventions

Mebendazole; Vincristine; Carboplatin; Temozolomide; Bevacizumab; Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Optic Nerve Diseases; Eye Diseases; Brain Stem Neoplasms; Infratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Coordination Complexes; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin

Study Officials

• Julie Krystal, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Developmental Therapeutics

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 23, 2013
• Study Start: October 22, 2013
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

US (1)