Study Assessing the Feasibility of a Surgery and Chemotherapy-Only in Child... | Recruiting
Study Assessing the Feasibility of ... | Recruiting
Study Assessing the Feasibility of a Surgery and Chemotherapy-Only in Children With Wnt Positive Medulloblastoma

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Medical Conditions
  • Medulloblastoma
Primary Contact Details
Kenneth Cohen Cohen, MD
410-614-5055
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02212574
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
Participants enrolling on this study will receive standard of care chemotherapy for Wnt positive medulloblastoma without the radiation therapy or the weekly chemotherapy that is given during radiation therapy.
Research Details
  • There will be 9 cycles of chemotherapy. There are two different kinds of cycles given. They are referred to as A and B.

    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.
Phase
N/A
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Lomustine, Drug : Vincristine, Drug : Cisplatin, Drug : Cyclophosphamide, Drug : Mesna, Drug : Vincristine

Study Arm Groups : Chemotherapy, Chemotherapy, Chemotherapy, Chemotherapy, Chemotherapy, Chemotherapy

Intervention Type
See Interventions above
Primary Outcome Measures
    Progression Free Survival; 3 years
Secondary Outcome Measures
    Patterns of Failure; 3 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
3 Years - 18 Years
Who Can Participate
Patients
Number of Participants
13
Participant Inclusion Criteria
    Inclusion Criteria:

    - Participants must have classical histology posterior fossa medulloblastoma as determined by institutional neuro-pathological evaluation.

    - Institutional beta- catenin staining must demonstrate nuclear reactivity by immunohistochemistry

    - 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:

    - Confirmation of beta-catenin nuclear reactivity by immunohistochemistry.

    - Monosomy 6 as determined by array CGH

    - Absence of MYCN or MYC amplification (as determined by FISH)

    - Absence of large-cell, anaplastic histology

    - 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

    - 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 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Trial Contact(s)
Primary Trial Contact
Kenneth Cohen Cohen, MD
410-614-5055
Other Trial Contacts
Tammy Scott, RN
410-614-5990
Countries Recruiting
Canada, Spain, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Pilot Study Assessing the Feasibility of a Surgery and Chemotherapy-Only Approach in the Upfront Therapy of Children With Wnt Positive Standard Risk Medulloblastoma
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
J1403
Sponsor(s)
Sidney Kimmel Comprehensive Cancer Center
Key Dates

Recruitment Start Date

Mar 2015

Recruitment End Date

Aug 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

07 Jul 2014

Date updated in source

10 Nov 2016