search
Back to results

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

Primary Purpose

Pilomyxoid Astrocytoma, Pilocytic Astrocytoma, Glioma, Astrocytic

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mebendazole
Vincristine
Carboplatin
Temozolomide
Bevacizumab
Irinotecan
Sponsored by
Julie Krystal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilomyxoid Astrocytoma focused on measuring 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

Eligibility Criteria

1 Year - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age > 1 year of age and ≤ 21 years of age
  2. Diagnosis

    2.1. 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.

    2.2 Group B - High-grade Glioma/Pontine Glioma Group:

    Histology: Biopsy-proven

    • Anaplastic astrocytoma
    • Glioblastoma multiforme
    • Gliosarcoma.

    Patients with primary spinal cord malignant gliomas are eligible.

    For primary brainstem tumors, histologic verification is not required. Patients are eligible when diagnosed with clinical and radiographic (MRI) evidence of tumors which diffusely involve the brainstem. Patients with tumors which intrinsically (greater than 50% intra-axial) involve the pons or pons and medulla or pons and midbrain or entire brainstem are eligible. Tumors may contiguously involve the thalamus or upper cervical cord.

  3. Timing of therapy:

    Patients must be enrolled before treatment begins. Treatment must start within 14 days of study enrollment.

    All clinical and laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated in the eligibility section.

  4. Adequate hematologic, renal, liver function as demonstrated by laboratory values.
  5. Negative pregnancy test in women of childbearing potential within 7 days of initiating investigational therapy
  6. Life expectancy ≥ 3 months
  7. Concurrent medications: It is recommended that patients are weaned off or are on a tapering dose of corticosteroids before starting therapy on study.
  8. Patient or legal guardian must give written, informed consent or assent (when applicable)
  9. Recent mothers must agree not to breast feed while receiving medications on study.

Exclusion criteria:

  1. Age < 1 year or > 21 years
  2. Patients who have known allergy to mebendazole or benzimidazole class drugs.
  3. 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 .
  4. Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapy.
  5. Pregnant female patients are not eligible for this study. Pregnancy tests with a negative result must be obtained in all post-menarchal females.
  6. Lactating females must agree they will not breastfeed a child while on this study.
  7. 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.
  8. Patients who are unable to take oral medications because of significant vomiting will be excluded.
  9. 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

  10. 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

Sites / Locations

  • Cohen Children's Medical Center of New YorkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low-grade Glioma

High-grade Glioma/Pontine Glioma

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Survival of patients with low-grade gliomas
3-year event-free survival (EFS) and overall survival (OS) of patients with low-grade gliomas treated with carboplatin, vincristine, temozolomide, and mebendazole in combination following surgical resection, to the extent feasible.
Survival of patients with high-grade gliomas
3-year event-free survival (EFS) and overall survival (OS) of patients with high-grade gliomas treated with bevacizumab, irinotecan, and mebendazole in combination following surgical resection to the extent feasible and local irradiation.
Frequency of cerebrospinal fluid (CSF) dissemination in pilomyxoid astrocytoma
The frequency of tumor dissemination in the CSF of patients with pilomyxoid astrocytomas treated with carboplatin, vincristine, temozolomide, and mebendazole.
Partial or complete response rate on MRI of patients with high-grade gliomas/pontine gliomas
The percentage of patients demonstrating a partial (greater than 50% decrease in tumor volume in 3 dimensions) or complete response on MRI in patients with high-grade gliomas treated with mebendazole in combination with bevacizumab and irinotecan, after surgical resection, to the extent feasible and local irradiation.
Partial or complete response rate on MRI of patients with low-grade gliomas
The percentage of patients demonstrating a partial (greater than 50% decrease in tumor volume in 3 dimensions) or complete response on MRI in patients with low-grade gliomas treated with mebendazole in combination with vincristine, carboplatin and temozolomide after surgical resection, to the extent feasible.

Full Information

First Posted
April 16, 2013
Last Updated
April 11, 2023
Sponsor
Julie Krystal
Collaborators
Janssen Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01837862
Brief Title
A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas
Official Title
A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2013 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Julie Krystal
Collaborators
Janssen Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
This is a phase I/II study of mebendazole in combination with standard of care agents for pediatric patients with gliomas. Patients with low-grade gliomas will receive a regimen of mebendazole in combination with vincristine, carboplatin, and temozolomide. Patients with high-grade gliomas and diffuse intrinsic pontine gliomas will receive a regimen of mebendazole in combination with bevacizumab and irinotecan. Surgical resection of the tumor will be attempted initially with the goal of achieving a gross total resection without substantial neurologic deficit. Subtotal resection may be preferable depending on the location of the tumor. Optic pathway gliomas and diffuse intrinsic pontine gliomas may remain unresected. Patients with high-grade gliomas or diffuse intrinsic pontine gliomas will undergo local irradiation of their tumor before beginning protocol treatment. Low-grade glioma patients will not receive radiation therapy. Patients 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. Patients with eligible tumors will be consented for enrollment into the study. The study patients will be divided into two groups (low-grade glioma and high-grade/pontine glioma) for the purpose of determining the maximally tolerated dose of mebendazole. These two groups will be treated independently with regard to patient accrual, dose escalation, and evaluation of toxicity. In addition to their standard chemotherapy regimen, patients in both cohorts will receive mebendazole. Mebendazole doses will be escalated from the initial dose level of 50 mg/kg/day divided twice daily, to a second dose level of 100 mg/kg/day divided twice daily, to the final dose level of 200 mg/kg/day divided twice daily, in cohorts of three patients per dose level. A standard "3+3" design will be used for determining dose escalation. Phase I safety monitoring for the low-grade group will take place during a trial period beginning with start of therapy and ending following the tenth week of induction therapy. Phase I safety monitoring for the high-grade/pontine glioma group will take place during a trial period beginning with the start of maintenance therapy through the twelfth week of maintenance therapy (3 cycles). After determination of maximally tolerated dose for each group, the study will continue to evaluate efficacy of this regimen. The study will be amended for the maximally tolerated dose for each group to be used in the remainder of the study. Patients currently on study will continue with maintenance therapy. To document the degree of residual tumor, standard whole brain MRI with and without contrast (gadolinium) will be performed following a specified intervals. Following completion of therapy, patients will continue to be monitored by MRI to assess progression-free and overall-survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-grade Glioma
Arm Type
Experimental
Arm Description
Patients on the low-grade arm will receive treatment with seven 10-week cycles of carboplatin, vincristine, temozolomide, and mebendazole.
Arm Title
High-grade Glioma/Pontine Glioma
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Mebendazole
Other Intervention Name(s)
Vermox
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Vincristine
Other Intervention Name(s)
Oncovin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
Temodar
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
CPT-11, Camptosar
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximally tolerated dose of mebendazole in combination with vincristine, carboplatin, and temozolomide
Description
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.
Time Frame
Assessed after the 10 week Induction cycle
Title
Maximally tolerated dose of mebendazole in combination with bevacizumab and irinotecan.
Description
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.
Time Frame
Assessed after the first 3 maintenance cycles (12 weeks)
Secondary Outcome Measure Information:
Title
Survival of patients with low-grade gliomas
Description
3-year event-free survival (EFS) and overall survival (OS) of patients with low-grade gliomas treated with carboplatin, vincristine, temozolomide, and mebendazole in combination following surgical resection, to the extent feasible.
Time Frame
3-years post-treatment
Title
Survival of patients with high-grade gliomas
Description
3-year event-free survival (EFS) and overall survival (OS) of patients with high-grade gliomas treated with bevacizumab, irinotecan, and mebendazole in combination following surgical resection to the extent feasible and local irradiation.
Time Frame
3-years post-treatment
Title
Frequency of cerebrospinal fluid (CSF) dissemination in pilomyxoid astrocytoma
Description
The frequency of tumor dissemination in the CSF of patients with pilomyxoid astrocytomas treated with carboplatin, vincristine, temozolomide, and mebendazole.
Time Frame
3 years post-treatment
Title
Partial or complete response rate on MRI of patients with high-grade gliomas/pontine gliomas
Description
The percentage of patients demonstrating a partial (greater than 50% decrease in tumor volume in 3 dimensions) or complete response on MRI in patients with high-grade gliomas treated with mebendazole in combination with bevacizumab and irinotecan, after surgical resection, to the extent feasible and local irradiation.
Time Frame
3-years post-treatment
Title
Partial or complete response rate on MRI of patients with low-grade gliomas
Description
The percentage of patients demonstrating a partial (greater than 50% decrease in tumor volume in 3 dimensions) or complete response on MRI in patients with low-grade gliomas treated with mebendazole in combination with vincristine, carboplatin and temozolomide after surgical resection, to the extent feasible.
Time Frame
3-years post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 1 year of age and ≤ 21 years of age Diagnosis 2.1. 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. 2.2 Group B - High-grade Glioma/Pontine Glioma Group: Histology: Biopsy-proven Anaplastic astrocytoma Glioblastoma multiforme Gliosarcoma. Patients with primary spinal cord malignant gliomas are eligible. For primary brainstem tumors, histologic verification is not required. Patients are eligible when diagnosed with clinical and radiographic (MRI) evidence of tumors which diffusely involve the brainstem. Patients with tumors which intrinsically (greater than 50% intra-axial) involve the pons or pons and medulla or pons and midbrain or entire brainstem are eligible. Tumors may contiguously involve the thalamus or upper cervical cord. Timing of therapy: Patients must be enrolled before treatment begins. Treatment must start within 14 days of study enrollment. All clinical and laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated in the eligibility section. Adequate hematologic, renal, liver function as demonstrated by laboratory values. Negative pregnancy test in women of childbearing potential within 7 days of initiating investigational therapy Life expectancy ≥ 3 months Concurrent medications: It is recommended that patients are weaned off or are on a tapering dose of corticosteroids before starting therapy on study. Patient or legal guardian must give written, informed consent or assent (when applicable) Recent mothers must agree not to breast feed while receiving medications on study. Exclusion criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Krystal, MD
Phone
718-470-3460
Email
Jkrystal12@northwell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Derek R Hanson, MD
Phone
551-996-5437
Email
DHanson@hackensackumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Krystal, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cohen Children's Medical Center of New York
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Krystal, MD
Phone
718-470-3460
Email
Jkrystal12@northwell.edu
First Name & Middle Initial & Last Name & Degree
Mark P Atlas, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
10515229
Citation
Tihan T, Fisher PG, Kepner JL, Godfraind C, McComb RD, Goldthwaite PT, Burger PC. Pediatric astrocytomas with monomorphous pilomyxoid features and a less favorable outcome. J Neuropathol Exp Neurol. 1999 Oct;58(10):1061-8. doi: 10.1097/00005072-199910000-00004.
Results Reference
background
PubMed Identifier
16048293
Citation
Komotar RJ, Mocco J, Jones JE, Zacharia BE, Tihan T, Feldstein NA, Anderson RC. Pilomyxoid astrocytoma: diagnosis, prognosis, and management. Neurosurg Focus. 2005 Jun 15;18(6A):E7.
Results Reference
background
PubMed Identifier
20461521
Citation
Paraskevopoulos D, Patsalas I, Karkavelas G, Foroglou N, Magras I, Selviaridis P. Pilomyxoid astrocytoma of the cervical spinal cord in a child with rapid progression into glioblastoma: case report and literature review. Childs Nerv Syst. 2011 Feb;27(2):313-21. doi: 10.1007/s00381-010-1171-5. Epub 2010 May 12.
Results Reference
background
PubMed Identifier
15617606
Citation
Komotar RJ, Carson BS, Rao C, Chaffee S, Goldthwaite PT, Tihan T. Pilomyxoid astrocytoma of the spinal cord: report of three cases. Neurosurgery. 2005;56(1):191. doi: 10.1227/01.NEU.0000146212.95421.B3.
Results Reference
background
PubMed Identifier
10571199
Citation
Bauman G, Lote K, Larson D, Stalpers L, Leighton C, Fisher B, Wara W, MacDonald D, Stitt L, Cairncross JG. Pretreatment factors predict overall survival for patients with low-grade glioma: a recursive partitioning analysis. Int J Radiat Oncol Biol Phys. 1999 Nov 1;45(4):923-9. doi: 10.1016/s0360-3016(99)00284-9.
Results Reference
background
PubMed Identifier
11786699
Citation
Desai KI, Nadkarni TD, Muzumdar DP, Goel A. Prognostic factors for cerebellar astrocytomas in children: a study of 102 cases. Pediatr Neurosurg. 2001 Dec;35(6):311-7. doi: 10.1159/000050443.
Results Reference
background
PubMed Identifier
9256121
Citation
Gajjar A, Sanford RA, Heideman R, Jenkins JJ, Walter A, Li Y, Langston JW, Muhlbauer M, Boyett JM, Kun LE. Low-grade astrocytoma: a decade of experience at St. Jude Children's Research Hospital. J Clin Oncol. 1997 Aug;15(8):2792-9. doi: 10.1200/JCO.1997.15.8.2792.
Results Reference
background
PubMed Identifier
9647172
Citation
Wisoff JH, Boyett JM, Berger MS, Brant C, Li H, Yates AJ, McGuire-Cullen P, Turski PA, Sutton LN, Allen JC, Packer RJ, Finlay JL. Current neurosurgical management and the impact of the extent of resection in the treatment of malignant gliomas of childhood: a report of the Children's Cancer Group trial no. CCG-945. J Neurosurg. 1998 Jul;89(1):52-9. doi: 10.3171/jns.1998.89.1.0052.
Results Reference
background
PubMed Identifier
10603023
Citation
Finlay JL, Wisoff JH. The impact of extent of resection in the management of malignant gliomas of childhood. Childs Nerv Syst. 1999 Nov;15(11-12):786-8. doi: 10.1007/s003810050471.
Results Reference
background
PubMed Identifier
7897512
Citation
Pollack IF, Claassen D, al-Shboul Q, Janosky JE, Deutsch M. Low-grade gliomas of the cerebral hemispheres in children: an analysis of 71 cases. J Neurosurg. 1995 Apr;82(4):536-47. doi: 10.3171/jns.1995.82.4.0536.
Results Reference
background
PubMed Identifier
9126887
Citation
Packer RJ, Ater J, Allen J, Phillips P, Geyer R, Nicholson HS, Jakacki R, Kurczynski E, Needle M, Finlay J, Reaman G, Boyett JM. Carboplatin and vincristine chemotherapy for children with newly diagnosed progressive low-grade gliomas. J Neurosurg. 1997 May;86(5):747-54. doi: 10.3171/jns.1997.86.5.0747.
Results Reference
background
PubMed Identifier
1851047
Citation
Conway PD, Oechler HW, Kun LE, Murray KJ. Importance of histologic condition and treatment of pediatric cerebellar astrocytoma. Cancer. 1991 Jun 1;67(11):2772-5. doi: 10.1002/1097-0142(19910601)67:113.0.co;2-#.
Results Reference
background
PubMed Identifier
11597812
Citation
Fisher BJ, Leighton CC, Vujovic O, Macdonald DR, Stitt L. Results of a policy of surveillance alone after surgical management of pediatric low grade gliomas. Int J Radiat Oncol Biol Phys. 2001 Nov 1;51(3):704-10. doi: 10.1016/s0360-3016(01)01705-9.
Results Reference
background
PubMed Identifier
8388548
Citation
Duffner PK, Horowitz ME, Krischer JP, Friedman HS, Burger PC, Cohen ME, Sanford RA, Mulhern RK, James HE, Freeman CR, et al. Postoperative chemotherapy and delayed radiation in children less than three years of age with malignant brain tumors. N Engl J Med. 1993 Jun 17;328(24):1725-31. doi: 10.1056/NEJM199306173282401.
Results Reference
background
PubMed Identifier
8490847
Citation
Brown MT, Friedman HS, Oakes WJ, Boyko OB, Hockenberger B, Schold SC Jr. Chemotherapy for pilocytic astrocytomas. Cancer. 1993 May 15;71(10):3165-72. doi: 10.1002/1097-0142(19930515)71:103.0.co;2-n.
Results Reference
background
PubMed Identifier
7782852
Citation
Gajjar A, Bhargava R, Jenkins JJ, Heideman R, Sanford RA, Langston JW, Walter AW, Kuttesch JF, Muhlbauer M, Kun LE. Low-grade astrocytoma with neuraxis dissemination at diagnosis. J Neurosurg. 1995 Jul;83(1):67-71. doi: 10.3171/jns.1995.83.1.0067.
Results Reference
background
PubMed Identifier
16850101
Citation
Ceppa EP, Bouffet E, Griebel R, Robinson C, Tihan T. The pilomyxoid astrocytoma and its relationship to pilocytic astrocytoma: report of a case and a critical review of the entity. J Neurooncol. 2007 Jan;81(2):191-6. doi: 10.1007/s11060-006-9216-z. Epub 2006 Jul 19.
Results Reference
background
PubMed Identifier
19414328
Citation
Tsugu H, Oshiro S, Yanai F, Komatsu F, Abe H, Fukushima T, Nomura Y, Matsumoto S, Nabeshima K, Takano K, Utsunomiya H. Management of pilomyxoid astrocytomas: our experience. Anticancer Res. 2009 Mar;29(3):919-26.
Results Reference
background
PubMed Identifier
3338054
Citation
Lefkowitz IB, Packer RJ, Sutton LN, Siegel KR, Bruce DA, Evans AE, Schut L. Results of the treatment of children with recurrent gliomas with lomustine and vincristine. Cancer. 1988 Mar 1;61(5):896-902. doi: 10.1002/1097-0142(19880301)61:53.0.co;2-c.
Results Reference
background
PubMed Identifier
1901597
Citation
Petronio J, Edwards MS, Prados M, Freyberger S, Rabbitt J, Silver P, Levin VA. Management of chiasmal and hypothalamic gliomas of infancy and childhood with chemotherapy. J Neurosurg. 1991 May;74(5):701-8. doi: 10.3171/jns.1991.74.5.0701.
Results Reference
background
PubMed Identifier
1732426
Citation
Friedman HS, Krischer JP, Burger P, Oakes WJ, Hockenberger B, Weiner MD, Falletta JM, Norris D, Ragab AH, Mahoney DH Jr, et al. Treatment of children with progressive or recurrent brain tumors with carboplatin or iproplatin: a Pediatric Oncology Group randomized phase II study. J Clin Oncol. 1992 Feb;10(2):249-56. doi: 10.1200/JCO.1992.10.2.249.
Results Reference
background
PubMed Identifier
3345069
Citation
Packer RJ, Sutton LN, Bilaniuk LT, Radcliffe J, Rosenstock JG, Siegel KR, Bunin GR, Savino PJ, Bruce DA, Schut L. Treatment of chiasmatic/hypothalamic gliomas of childhood with chemotherapy: an update. Ann Neurol. 1988 Jan;23(1):79-85. doi: 10.1002/ana.410230113.
Results Reference
background
PubMed Identifier
7842408
Citation
Janss AJ, Grundy R, Cnaan A, Savino PJ, Packer RJ, Zackai EH, Goldwein JW, Sutton LN, Radcliffe J, Molloy PT, et al. Optic pathway and hypothalamic/chiasmatic gliomas in children younger than age 5 years with a 6-year follow-up. Cancer. 1995 Feb 15;75(4):1051-9. doi: 10.1002/1097-0142(19950215)75:43.0.co;2-s.
Results Reference
background
PubMed Identifier
19841428
Citation
Sievert AJ, Fisher MJ. Pediatric low-grade gliomas. J Child Neurol. 2009 Nov;24(11):1397-408. doi: 10.1177/0883073809342005.
Results Reference
background
PubMed Identifier
12816259
Citation
Burkhard C, Di Patre PL, Schuler D, Schuler G, Yasargil MG, Yonekawa Y, Lutolf UM, Kleihues P, Ohgaki H. A population-based study of the incidence and survival rates in patients with pilocytic astrocytoma. J Neurosurg. 2003 Jun;98(6):1170-4. doi: 10.3171/jns.2003.98.6.1170.
Results Reference
background
PubMed Identifier
3392563
Citation
Wallner KE, Gonzales MF, Edwards MS, Wara WM, Sheline GE. Treatment results of juvenile pilocytic astrocytoma. J Neurosurg. 1988 Aug;69(2):171-6. doi: 10.3171/jns.1988.69.2.0171.
Results Reference
background
PubMed Identifier
8207524
Citation
Mamelak AN, Prados MD, Obana WG, Cogen PH, Edwards MS. Treatment options and prognosis for multicentric juvenile pilocytic astrocytoma. J Neurosurg. 1994 Jul;81(1):24-30. doi: 10.3171/jns.1994.81.1.0024.
Results Reference
background
PubMed Identifier
8009427
Citation
Dutton JJ. Gliomas of the anterior visual pathway. Surv Ophthalmol. 1994 Mar-Apr;38(5):427-52. doi: 10.1016/0039-6257(94)90173-2.
Results Reference
background
PubMed Identifier
16809032
Citation
Opocher E, Kremer LC, Da Dalt L, van de Wetering MD, Viscardi E, Caron HN, Perilongo G. Prognostic factors for progression of childhood optic pathway glioma: a systematic review. Eur J Cancer. 2006 Aug;42(12):1807-16. doi: 10.1016/j.ejca.2006.02.022. Epub 2006 Jun 30.
Results Reference
background
PubMed Identifier
9875044
Citation
Cappelli C, Grill J, Raquin M, Pierre-Kahn A, Lellouch-Tubiana A, Terrier-Lacombe MJ, Habrand JL, Couanet D, Brauner R, Rodriguez D, Hartmann O, Kalifa C. Long-term follow up of 69 patients treated for optic pathway tumours before the chemotherapy era. Arch Dis Child. 1998 Oct;79(4):334-8. doi: 10.1136/adc.79.4.334.
Results Reference
background
PubMed Identifier
11096362
Citation
Silva MM, Goldman S, Keating G, Marymont MA, Kalapurakal J, Tomita T. Optic pathway hypothalamic gliomas in children under three years of age: the role of chemotherapy. Pediatr Neurosurg. 2000 Sep;33(3):151-8. doi: 10.1159/000028996.
Results Reference
background
PubMed Identifier
17705175
Citation
Nicholson HS, Kretschmar CS, Krailo M, Bernstein M, Kadota R, Fort D, Friedman H, Harris MB, Tedeschi-Blok N, Mazewski C, Sato J, Reaman GH. Phase 2 study of temozolomide in children and adolescents with recurrent central nervous system tumors: a report from the Children's Oncology Group. Cancer. 2007 Oct 1;110(7):1542-50. doi: 10.1002/cncr.22961.
Results Reference
background
PubMed Identifier
6613972
Citation
Gil-Grande LA, Boixeda D, Garcia-Hoz F, Barcena R, Lledo A, Suarez E, Pascasio JM, Moreira V. Treatment of liver hydatid disease with mebendazole: a prospective study of thirteen cases. Am J Gastroenterol. 1983 Sep;78(9):584-8.
Results Reference
background
PubMed Identifier
21764822
Citation
Bai RY, Staedtke V, Aprhys CM, Gallia GL, Riggins GJ. Antiparasitic mebendazole shows survival benefit in 2 preclinical models of glioblastoma multiforme. Neuro Oncol. 2011 Sep;13(9):974-82. doi: 10.1093/neuonc/nor077. Epub 2011 Jul 15.
Results Reference
background
PubMed Identifier
12231542
Citation
Mukhopadhyay T, Sasaki J, Ramesh R, Roth JA. Mebendazole elicits a potent antitumor effect on human cancer cell lines both in vitro and in vivo. Clin Cancer Res. 2002 Sep;8(9):2963-9.
Results Reference
background
PubMed Identifier
12479701
Citation
Sasaki J, Ramesh R, Chada S, Gomyo Y, Roth JA, Mukhopadhyay T. The anthelmintic drug mebendazole induces mitotic arrest and apoptosis by depolymerizing tubulin in non-small cell lung cancer cells. Mol Cancer Ther. 2002 Nov;1(13):1201-9.
Results Reference
background
PubMed Identifier
18667591
Citation
Doudican N, Rodriguez A, Osman I, Orlow SJ. Mebendazole induces apoptosis via Bcl-2 inactivation in chemoresistant melanoma cells. Mol Cancer Res. 2008 Aug;6(8):1308-15. doi: 10.1158/1541-7786.MCR-07-2159. Epub 2008 Jul 30.
Results Reference
background
PubMed Identifier
21454232
Citation
Dobrosotskaya IY, Hammer GD, Schteingart DE, Maturen KE, Worden FP. Mebendazole monotherapy and long-term disease control in metastatic adrenocortical carcinoma. Endocr Pract. 2011 May-Jun;17(3):e59-62. doi: 10.4158/EP10390.CR.
Results Reference
background
PubMed Identifier
10656037
Citation
Vutova K, Mechkov G, Vachkov P, Petkov R, Georgiev P, Handjiev S, Ivanov A, Todorov T. Effect of mebendazole on human cystic echinococcosis: the role of dosage and treatment duration. Ann Trop Med Parasitol. 1999 Jun;93(4):357-65. doi: 10.1080/00034989958357.
Results Reference
background
PubMed Identifier
498051
Citation
Kepes JJ, Rubinstein LJ, Eng LF. Pleomorphic xanthoastrocytoma: a distinctive meningocerebral glioma of young subjects with relatively favorable prognosis. A study of 12 cases. Cancer. 1979 Nov;44(5):1839-52. doi: 10.1002/1097-0142(197911)44:53.0.co;2-0.
Results Reference
background
PubMed Identifier
20582976
Citation
Rao AA, Laack NN, Giannini C, Wetmore C. Pleomorphic xanthoastrocytoma in children and adolescents. Pediatr Blood Cancer. 2010 Aug;55(2):290-4. doi: 10.1002/pbc.22490.
Results Reference
background
PubMed Identifier
10223246
Citation
Giannini C, Scheithauer BW, Burger PC, Brat DJ, Wollan PC, Lach B, O'Neill BP. Pleomorphic xanthoastrocytoma: what do we really know about it? Cancer. 1999 May 1;85(9):2033-45.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs