Purpose

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.

Category

IRB Number
20170671HU
NCT Number
NCT02724579
Open to Enrollment
Yes
Sponsor
Children's Oncology Group -



Study Contact

Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu

Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu

Principal Investigator
Anne-Marie Langevin

Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu

Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu



Eligibility

Eligible Ages
Between 3 Years and 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2
      Study Type
      Interventional
      Allocation
      N/A
      Intervention Model
      Single Group Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Medulloblastoma

      2. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Treatment (reduced radiation therapy and chemotherapy)

      		RADIATION THERAPY: Beginning 4-5 weeks after surgery, patients undergo craniospinal radiation therapy 5 days a week for 6 weeks. MAINTENANCE THERAPY (WEEKS 1, 3, 5, and 7): Beginning 4-6 weeks after completion of radiation therapy patients receive lomustine PO on day 1, vincristine sulfate 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.
    2. Drug: Cisplatin

      Given IV

      Other names:

      • Abiplatin
      • Blastolem
      • Briplatin
      • CDDP
      • Cis-diammine-dichloroplatinum
      • Cis-diamminedichloridoplatinum
      • Cis-diamminedichloro Platinum (II)
      • Cis-diamminedichloroplatinum

    3. Other: Laboratory Biomarker Analysis

      Correlative studies

    4. Radiation: Radiation Therapy

      Undergo craniospinal radiation therapy

      Other names:

      • Cancer Radiotherapy
      • ENERGY_TYPE
      • Irradiate
      • Irradiated
      • Irradiation
      • Radiation
      • Radiation Therapy, NOS
      • Radiotherapeutics
      • Radiotherapy
      • RT
      • Therapy, Radia

    5. Drug: Vincristine Sulfate

      Given IV or via minibag

      Other names:

      • Kyocristine
      • Leurocristine Sulfate
      • Leurocristine, sulfate
      • Oncovin
      • Vincasar
      • Vincosid
      • Vincrex
      • Vincristine, sulfate

    6. Drug: Cyclophosphamide

      Given IV

      Other names:

      • (-)-Cyclophosphamide
      • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
      • Carloxan
      • Ciclofosfamida
      • Ciclofosfamide
      • Cicloxal
      • Clafen <

    7. Drug: Lomustine

      Given PO

      Other names:

      • 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea
      • 1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-
      • Belustin
      • Belustine
      • CCNU
      • Cecenu
      • CeeNU
      • Chloroethylcyclohexylnitrosourea

    8. Drug: Vincristine

      Given IV or via minibag

      Other names:

      • Leurocristine
      • VCR
      • Vincrystine

      9.