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



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:3 - 21
Updated:8/9/2018
Start Date:October 2, 2017
End Date:May 31, 2025

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A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

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.

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.

Inclusion Criteria:

- Patients must be newly diagnosed and have a confirmed molecular diagnosis of classical
histologic type (non large cell/anaplastic [LC/A]) WNT medulloblastoma from rapid
central pathology screening review on APEC14B1 (immunohistochemistry [IHC]/molecular
screening [positive nuclear beta (B)-catenin by IHC and positive for catenin beta 1
[CTNNB1] mutation) and confirmation of =< 1.5 cm^2 maximal cross-sectional area of
residual tumor from rapid central imaging review

- Patient must have negative lumbar cerebrospinal fluid (CSF) cytology; CSF cytology for
staging should be performed preferably no sooner than 14 days post operatively to
avoid false positive CSF; ideally, CSF should be obtained between day 14 and day 21 to
allow for final staging status before enrollment onto the study

- Note: patients with positive CSF cytology obtained prior to 14 days after surgery
may have cytology repeated to determine eligibility and final CSF status

- Patients must have eligibility confirmed by rapid central imaging review on APEC14B1;
standard whole brain magnetic resonance imaging (MRI) with and without contrast
(gadolinium) and spine MRI with contrast (gadolinium) must be performed at the
following time points:

- Pre-operative to include an MRI of the brain with and without contrast (including
post-contrast three-dimensional [3D] T1-weighted image [T1WI] and post-contrast
fluid-attenuated inversion recovery [FLAIR])

- Pre-operative spinal MRI with gadolinium; post-operative staging spinal MRI may
be obtained if pre-operative imaging is not possible or is suboptimal;
pre-operative spine imaging is strongly preferred, due to the potential of
post-operative sequelae, which could affect metastasis detection

- Post-operative brain MRI within 72 hours of surgery

- Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1422

- Patients must be enrolled within 36 days of definitive diagnostic surgery (day 0)

- Note: patients must begin treatment within 36 days of definitive surgery

- Patients must have no previous radiotherapy or chemotherapy other than corticosteroids

- Peripheral absolute neutrophil count (ANC) >= 1000/uL

- Platelet count >= 100,000/uL (transfusion independent)

- Hemoglobin >= 10.0 g/dL (may receive red blood cell [RBC] transfusions)

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

- 3 to < 6 years of age: maximum (max) serum creatinine 0.8 mg/dL (males and
females)

- 6 to < 10 years of age: max serum creatinine 1 mg/dL (males and females)

- 10 to < 13 years of age: max serum creatinine 1.2 mg/dL (males and females)

- 13 to < 16 years of age: max serum creatinine 1.5 md/dL (males) and 1.4 md/dL
(females)

- >= 16 years of age: max serum creatinine 1.7 mg/dL (males) and 1.4 mg/dL
(females)

- The threshold creatinine values were derived from the Schwartz formula for
estimating GFR utilizing child length and stature data published by the
Centers for Disease Control and Prevention (CDC)

- Total or direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and

- Serum glutamate pyruvate (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L (for the
purpose of this study, the upper limit of normal [ULN] for SGPT is 45 U/L)

- Central nervous system function defined as:

- Patients with seizure disorder may be enrolled if on anticonvulsants and well
controlled

- Patients must not be in status epilepticus, a coma or on assisted ventilation at
the time of study enrollment

- All patients and/or their parents or legal guardians must sign a written informed
consent; assent, when appropriate, will be obtained according to institutional
guidelines

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met

Exclusion Criteria:

- Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar
CSF cytology are not eligible; patients who are unable to undergo a lumbar puncture
for assessment of CSF cytology are ineligible

- Patients must not have received any prior tumor-directed therapy other than surgical
intervention and corticosteroids

- Female patients who are pregnant are ineligible

- Lactating females are not eligible unless they have agreed not to breastfeed their
infants

- Female patients of childbearing potential are not eligible unless a negative pregnancy
test result has been obtained

- Sexually active patients of reproductive potential are not eligible unless they have
agreed to use an effective contraceptive method for the duration of their study
participation
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Hershey, PA
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Hollywood, Florida 33021
Principal Investigator: Iftikhar Hanif
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from
Hollywood, FL
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Principal Investigator: Wade T. Kyono
Phone: 808-983-6090
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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mi
from
Honolulu, HI
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Houston, Texas 77030
Principal Investigator: Jack M. Su
Phone: 713-798-1354
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from
Houston, TX
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Kamnesh R. Pradhan
Phone: 800-248-1199
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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from
Indianapolis, IN
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Indianapolis, Indiana 46260
Principal Investigator: Bassem I. Razzouk
Phone: 317-338-2194
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from
Indianapolis, IN
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Iowa City, Iowa 52242
Principal Investigator: Mariko Sato
Phone: 800-237-1225
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mi
from
Iowa City, IA
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Jacksonville, Florida 32207
Principal Investigator: Andrew W. Walter
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mi
from
Jacksonville, FL
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2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
Principal Investigator: Ray C. Pais
Phone: 865-541-8266
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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from
Knoxville, TN
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Las Vegas, Nevada 89109
Principal Investigator: Alan K. Ikeda
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from
Las Vegas, NV
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Las Vegas, Nevada 89144
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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from
Las Vegas, NV
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Sara Chaffee
Phone: 800-639-6918
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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mi
from
Lebanon, NH
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Lexington, Kentucky
Principal Investigator: Vlad C. Radulescu
Phone: 859-257-3379
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from
Lexington, KY
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: David L. Becton
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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mi
from
Little Rock, AR
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Albert Kheradpour
Phone: 909-558-3375
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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mi
from
Loma Linda, CA
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Lubbock, Texas 79430
Principal Investigator: Mohamad M. Al-Rahawan
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mi
from
Lubbock, TX
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Kenneth B. De Santes
Phone: 800-622-8922
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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from
Madison, WI
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Marshfield, Wisconsin 54449
Principal Investigator: Michael J. McManus
Phone: 800-782-8581
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from
Marshfield, WI
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Eugene Suh
Phone: 708-226-4357
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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mi
from
Maywood, IL
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Mesa, Arizona 85202
Principal Investigator: Hardeo K. Panchoosingh
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mi
from
Mesa, AZ
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Miami, Florida 33155
Principal Investigator: Enrique A. Escalon
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mi
from
Miami, FL
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: Jeffrey A. Knipstein
Phone: 414-955-4727
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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mi
from
Milwaukee, WI
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259 1st Street
Mineola, New York 11501
Principal Investigator: Mark E. Weinblatt
Phone: 516-663-3115
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mi
from
Mineola, NY
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Minneapolis, Minnesota 55455
Principal Investigator: Christopher L. Moertel
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from
Minneapolis, MN
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Morgantown, West Virginia 26505
Principal Investigator: Stephan R. Paul
Phone: 304-293-7374
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from
Morgantown, WV
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