Study Assessing the Feasibility of a Surgery and Chemotherapy-Only in Children With Wnt Positive Medulloblastoma
NCT ID: NCT02212574
Last Updated: 2021-11-05
Study Results
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View full resultsBasic Information
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TERMINATED
EARLY_PHASE1
6 participants
INTERVENTIONAL
2017-04-04
2018-11-09
Brief Summary
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Detailed Description
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Cycle A lasts for 6 weeks and Cycle B lasts for 4 weeks. B cycles are given after the completion of two A cycles.
Below are the details of the drugs and schedules for A and B cycles.
Cycle A (This cycle lasts 42 days)
* Lomustine (CCNU) is given by mouth on Day 1.
* Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15.
* Cisplatin is given directly into a vein over 8 hours on Day 1
Cycle B (This cycle lasts 28 days)
* Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2.
* MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours.
* Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8.
You may also get a supportive care drug called a myeloid growth factor (filgrastim or pegfilgrastim). This drug will help your blood counts recover after the chemotherapy is given.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chemotherapy
Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1. Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15. Cisplatin is given directly into a vein over 8 hours on Day 1. This cycle lasts 42 days.
Chemotherapy Cycle B Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2. MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours. Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8.This cycle lasts 28 days
Lomustine
Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1.
Vincristine
Chemotherapy Cycle A Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15.
Cisplatin
Chemotherapy Cycle A Cisplatin is given directly into a vein over 8 hours on Day 1.
Cyclophosphamide
Chemotherapy Cycle B Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2.
Mesna
Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours.
Vincristine
Chemotherapy Cycle B Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8.
Interventions
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Lomustine
Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1.
Vincristine
Chemotherapy Cycle A Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15.
Cisplatin
Chemotherapy Cycle A Cisplatin is given directly into a vein over 8 hours on Day 1.
Cyclophosphamide
Chemotherapy Cycle B Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2.
Mesna
Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours.
Vincristine
Chemotherapy Cycle B Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Sufficient pathologic material must be available for central analysis and review
* Tumors will be deemed Wnt positive if, at the time of central analysis, there is:
* Monosomy 6 as determined by array CGH
* Gene transcript detection by NanoString supporting Wnt+ medulloblastoma
* Absence of large-cell, anaplastic histology
* Nuclear b-catenin IHC will be determined, but not required for the diagnosis
* Absence of residual or disseminated disease as defined by the following criteria: Minimal residual disease as determined by post-operative imaging preferably performed within 48 hours of resection (and at most 28 days post-surgery), i.e. gross total resection or residual disease of \<1.5cm2 on post-operative imaging.
No evidence of metastatic disease in the brain, spine or cerebral spinal fluid (CSF). Assessments must include MRI imaging of the brain and spine with and without contrast and a lumbar puncture for CSF cytology
* Diagnostic imaging (pre and post contrast) must be forwarded to Dana-Farber Cancer Institute (DFCI) for central review to confirm eligibility
* Patients must not have had any radiation therapy or chemotherapy for medulloblastoma prior to study enrollment
* Patients must have a Lansky performance status of \>/=30 for children \</=10 years of age or a Karnofsky performance status of \> 30 for children \> 10 years of age.
* Participants must have normal organ and marrow function as defined below:
* Hemoglobin greater than 10 g/dL (can be transfused). Hemoglobin \<10 g/dL due to operative blood loss is permitted.
* Absolute neutrophil count \> 1.0x109/L
* Platelets \> 100,000/uL (non-transfused)
* Total bilirubin \<1.5 x upper limit normal
* SGOT (AST) or SGPT (ALT) \<2.5 x upper limit normal (ULN) for age
* Creatinine clearance or radioisotope GFR \>70 ml/min/1.73m2 or normal serum creatinine for patient's age and gender
* All females of child-bearing age must have a negative pregnancy test before being enrolled on study. All patients of child-bearing age must practice an effective method of birth control whilst undergoing chemotherapy on study.
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, lomustine, vincristine or cyclophosphamide.
3 Years
18 Years
ALL
No
Sponsors
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The Matthew Larson Foundation for Pediatric Brain Tumors
OTHER
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Kenneth Cohen, MD
Role: STUDY_CHAIR
Johns Hopkins University
Locations
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Phoenix Childrens Hospital Hematology/Oncology
Phoenix, Arizona, United States
Children's Hospital Colorado Center for Cancer & Blood Disorders
Aurora, Colorado, United States
M D Anderson Cancer Center-Orlando Pediatric Hematology/Oncology
Orlando, Florida, United States
All Children's Hospital Pediatric Hematology/Oncology
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta- Egleston Pediatric Neuro-Oncology
Atlanta, Georgia, United States
Ann and Robert H Lurie Children's Hospital of Chicago Hematology/Oncology
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine Pediatric Hematology/Oncology
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health and Science University Pediatric Hematology/Oncology
Portland, Oregon, United States
Seattle Children's Hospital Hematology/Oncology
Seattle, Washington, United States
Childrens Hospital of Wisconsin (Medical College of Wisconsin)
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NA_00091840
Identifier Type: OTHER
Identifier Source: secondary_id
J1403
Identifier Type: -
Identifier Source: org_study_id