Last updated on April 2019

Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma


Brief description of study

This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) of children >= 3 years of age with wingless-type MMTV integration site family (WNT)/WNT-driven average-risk medulloblastoma using reduced craniospinal radiotherapy (CSI) (18 Gray [Gy]) with a limited target volume boost to the tumor bed of 36 Gy for a total of 54 Gy and reduced chemotherapy approach (no vincristine [vincristine sulfate] during radiotherapy and reduced-dose maintenance chemotherapy) and to monitor the PFS for early evidence that the outcome is unacceptable.

SECONDARY OBJECTIVES:

I. To prospectively test the hypothesis that deoxyribonucleic acid (DNA) methylation profiling will result in ?real-time? classification of WNT-driven medulloblastoma.

II. To use the ALTE07C1 protocol to prospectively evaluate and longitudinally model the cognitive, social, emotional and behavioral functioning of children who are treated with reduced CSI (18 Gy) with a limited target volume boost to the tumor bed (to a total of 54 Gy) and reduced chemotherapy (reduced cisplatin, vincristine and lomustine [CCNU]).

TERTIARY OBJECTIVES:

I. To explore whether DNA methylation profiling of medulloblastoma samples will result in a ?real-time? predictive classification scheme for the Sonic Hedgehog (SHH), Group 3 and Group 4 medulloblastoma subgroups according to the Heidelberg classifier.

OUTLINE

RADIATION THERAPY: Beginning 4-5 weeks after surgery, patients undergo craniospinal radiation therapy 5 days a week for 6 weeks.

MAITENANCE THERAPY (WEEKS 1, 3, 5, and 7): Beginning 4-6 weeks after completion of radiation therapy patients receive lomustine orally (PO) on day 1, vincristine sulfate intravenously (IV) over 1 minute or via minibag on days 1, 8, and 15, and cisplatin IV over 6 hours on day

  1. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY (WEEKS 2, 4, AND 6): Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 2, mesna IV over 15-30 minutes on days 1 and 2, and vincristine sulfate IV over 1 minute or via minibag on days 1 and 8. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually for 6 years.

Clinical Study Identifier: NCT02724579

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Childrens Oncology Group

Philadelphia, PA United States
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Saint Mary's Hospital

West Palm Beach, FL United States
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Florida Hospital Orlando

Orlando, FL United States
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University of Virginia Cancer Center

Charlottesville, VA United States
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Cleveland Clinic Foundation

Cleveland, OH United States
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Inova Fairfax Hospital

Falls Church, VA United States
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Ochsner Medical Center Jefferson

New Orleans, LA United States
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Mount Sinai Hospital

New York, NY United States
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Children's Hospital of Alabama

Birmingham, AL United States
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Phoenix Childrens Hospital

Phoenix, AZ United States
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Arkansas Children's Hospital

Little Rock, AR United States
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Children's Hospital Los Angeles

Los Angeles, CA United States
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Nemours Children's Hospital

Orlando, FL United States
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Johns Hopkins All Children's Hospital

Saint Petersburg, FL United States
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University of Illinois

Chicago, IL United States
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Riley Hospital for Children

Indianapolis, IN United States
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Blank Children's Hospital

Des Moines, IA United States
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Children's Hospital New Orleans

New Orleans, LA United States
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Maine Children's Cancer Program

Scarborough, ME United States
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C S Mott Children's Hospital

Ann Arbor, MI United States
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Bronson Methodist Hospital

Kalamazoo, MI United States
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West Michigan Cancer Center

Kalamazoo, MI United States
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Mayo Clinic

Rochester, MN United States
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Columbia Regional

Columbia, MO United States
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The Childrens Mercy Hospital

Kansas City, MO United States
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Mercy Hospital Saint Louis

Saint Louis, MO United States
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Morristown Medical Center

Morristown, NJ United States
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Saint Peter's University Hospital

New Brunswick, NJ United States
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Albany Medical Center

Albany, NY United States
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NYU Winthrop Hospital

Mineola, NY United States
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University of Rochester

Rochester, NY United States
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New York Medical College

Valhalla, NY United States
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East Carolina University

Greenville, NC United States
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Geisinger Medical Center

Danville, PA United States
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Rhode Island Hospital

Providence, RI United States
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Palmetto Health Richland

Columbia, SC United States
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T C Thompson Children's Hospital

Chattanooga, TN United States
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Driscoll Children's Hospital

Corpus Christi, TX United States
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El Paso Children's Hospital

El Paso, TX United States
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University Medical Center

Lubbock, TX United States
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Primary Children's Hospital

Salt Lake City, UT United States
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Seattle Children's Hospital

Seattle, WA United States
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Marshfield Clinic

Marshfield, WI United States
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Recruitment Status: Open


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