Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02017964 : Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed, Non-Metastatic Desmoplastic Medulloblastoma
PhasePhase 2
AgesMin: N/A Max: 47 Months
Eligibility
Inclusion Criteria:

- Patients must be newly diagnosed and have a confirmed histologic diagnosis of nodular
desmoplastic (ND) medulloblastoma or medulloblastoma with extensive nodularity (MBEN)
from rapid central pathology screening review; please note: patients with Gorlin
syndrome are eligible

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

- Patients must have:

- Pre-operative cranial magnetic resonance imaging (MRI) (recommended with
gadolinium) or pre-operative computed tomography (CT) (recommended with
contrast)

- Post-operative cranial MRI with and without gadolinium within 72 hours of
surgery

- Spinal MRI pre-op with and without gadolinium or post-op with and without
gadolinium within 72 hours of surgery

- Patients must be enrolled on study within 31 days of definitive surgical resection at
which time tissue is acquired to determine a diagnosis; patients must be enrolled
before treatment begins; the date protocol therapy is projected to start must be no
later than five (5) calendar days after the date of study enrollment; patients who
are started on protocol therapy on a Phase II study prior to study enrollment will be
considered ineligible

- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1 or 2; use Lansky for patients =< 16 years of age

- Patients must have a life expectancy of >= 8 weeks

- Patients who are receiving dexamethasone must be on a stable dose for at least 1 week
prior to study entry

- 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:

- 1 month to < 6 months: 0.4 mg/dL

- 6 months to < 1 year: 0.5 mg/dL

- 1 to < 2 years: 0.6 mg/dL

- 2 to < 6 years: 0.8 mg/dL

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

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x
upper limit of normal (ULN) for age

- 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, coma or assisted ventilation prior to study
enrollment

Exclusion Criteria:

- Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar
CSF cytology are not eligible

- Patients must not have received any prior tumor-directed therapy other than surgical
intervention and corticosteroids
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02017964      |      Link to official Clinicaltrials.gov listing
Locations
Perth, Western Australia
Australia

Facility: Princess Margaret Hospital for Children
Investigator: Catherine H. Cole
Contact: Catherine H. Cole Phone: (08) 9340 8330
Click HERE to send email to this center

Vancouver, British Columbia
Canada

Facility: British Columbia Children's Hospital
Investigator: Caron Strahlendorf
Contact: Caron Strahlendorf Phone: 604-875-2345ext6477
Email not avaialable

Winnipeg, Manitoba
Canada

Facility: CancerCare Manitoba
Investigator: Rochelle A. Yanofsky
Contact: Rochelle A. Yanofsky Phone: 866-561-1026
Click HERE to send email to this center

Halifax, Nova Scotia
Canada

Facility: IWK Health Centre
Investigator: Conrad V. Fernandez
Contact: Conrad V. Fernandez Phone: 902-470-8394
Email not avaialable

Toronto, Ontario
Canada

Facility: Hospital for Sick Children
Investigator: Eric Bouffet
Contact: Eric Bouffet Phone: 416-813-7654ext2027
Click HERE to send email to this center

Montreal, Quebec
Canada

Facility: Centre Hospitalier Universitaire Sainte-Justine
Investigator: Yvan Samson
Contact: Yvan Samson Phone: 514-345-4931
Email not avaialable

Ste-Foy, Quebec
Canada

Facility: Centre Hospitalier Universitaire de Quebec
Investigator: Bruno Michon
Contact: Bruno Michon Phone: 418-525-4444
Email not avaialable

Birmingham, Alabama
Facility: Children's Hospital of Alabama
Investigator: Alyssa T. Reddy
Contact: Alyssa T. Reddy Phone: 205-934-0309
Email not avaialable

Downey, California
Facility: Southern California Permanente Medical Group
Investigator: Robert M. Cooper
Contact: Robert M. Cooper Phone: 626-564-3455
Email not avaialable

Loma Linda, California
Facility: Loma Linda University Medical Center
Investigator: Albert Kheradpour
Contact: Albert Kheradpour Phone: 909-558-3375
Email not avaialable

Orange, California
Facility: Childrens Hospital of Orange County
Investigator: Violet Shen
Contact: Violet Shen Phone: 714-997-3000
Email not avaialable

Sacramento, California
Facility: University of California at Davis Cancer Center
Investigator: Jay Michael S. Balagtas
Contact: Jay Michael S. Balagtas Phone: 916-734-3089
Email not avaialable

Hartford, Connecticut
Facility: Connecticut Children's Medical Center
Investigator: Michael S. Isakoff
Contact: Michael S. Isakoff Phone: 860-545-9981
Email not avaialable

Wilmington, Delaware
Facility: Alfred I duPont Hospital for Children
Investigator: Christopher N. Frantz
Contact: Christopher N. Frantz Phone: 302-651-5755
Email not avaialable

Washington, District of Columbia
Facility: Children's National Medical Center
Investigator: Jeffrey S. Dome
Contact: Jeffrey S. Dome Phone: 202-884-2549
Email not avaialable

Jacksonville, Florida
Facility: Nemours Children's Clinic-Jacksonville South
Investigator: Scott M. Bradfield
Contact: Scott M. Bradfield Phone: 904-697-3529
Email not avaialable

Orlando, Florida
Facility: Florida Hospital Orlando
Investigator: Fouad M. Hajjar
Contact: Fouad M. Hajjar Phone: 407-303-5623
Email not avaialable

Orlando, Florida
Facility: Arnold Palmer Hospital for Children
Investigator: Vincent F. Giusti
Contact: Vincent F. Giusti Phone: 321-841-7246
Click HERE to send email to this center

Orlando, Florida
Facility: Nemours Children's Hospital
Investigator: Ramamoorthy Nagasubramanian
Contact: Ramamoorthy Nagasubramanian Phone: 407-650-7150
Email not avaialable

Pensacola, Florida
Facility: Nemours Children's Clinic - Pensacola
Investigator: Jeffrey H. Schwartz
Contact: Jeffrey H. Schwartz Phone: 904-697-3529
Email not avaialable

Saint Petersburg, Florida
Facility: All Children's Hospital
Investigator: Gregory A. Hale
Contact: Gregory A. Hale Phone: 727-767-2423
Click HERE to send email to this center

Tampa, Florida
Facility: Saint Joseph Children's Hospital of Tampa
Investigator: Hardeo K. Panchoosingh
Contact: Hardeo K. Panchoosingh Phone: 800-882-4123
Email not avaialable

West Palm Beach, Florida
Facility: Saint Mary's Hospital
Investigator: Narayana Gowda
Contact: Narayana Gowda Phone: 888-823-5923
Click HERE to send email to this center

Atlanta, Georgia
Facility: Children's Healthcare of Atlanta - Egleston
Investigator: Tobey J. MacDonald
Contact: Tobey J. MacDonald Phone: 404-785-1112
Email not avaialable

Chicago, Illinois
Facility: Lurie Children's Hospital-Chicago
Investigator: Stewart Goldman
Contact: Stewart Goldman Phone: 773-880-4562
Email not avaialable

Peoria, Illinois
Facility: Saint Jude Midwest Affiliate
Investigator: Karen S. Fernandez
Contact: Karen S. Fernandez Phone: 309-655-3258
Email not avaialable

Indianapolis, Indiana
Facility: Riley Hospital for Children
Investigator: Robert J. Fallon
Contact: Robert J. Fallon Phone: 317-274-2552
Email not avaialable

Des Moines, Iowa
Facility: Blank Children's Hospital
Investigator: Wendy L. Woods-Swafford
Contact: Wendy L. Woods-Swafford Phone: 515-241-6729
Email not avaialable

Lexington, Kentucky
Facility: University of Kentucky
Investigator: Lars M. Wagner
Contact: Lars M. Wagner Phone: 859-257-3379
Email not avaialable

Louisville, Kentucky
Facility: Kosair Children's Hospital
Investigator: Kenneth G. Lucas
Contact: Kenneth G. Lucas Phone: 866-530-5516
Email not avaialable

New Orleans, Louisiana
Facility: Children's Hospital New Orleans
Investigator: Lolie C. Yu
Contact: Lolie C. Yu Phone: 504-894-5377
Email not avaialable

New Orleans, Louisiana
Facility: Ochsner Medical Center Jefferson
Investigator: Craig Lotterman
Contact: Craig Lotterman Phone: 888-562-4763
Email not avaialable

Baltimore, Maryland
Facility: Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Investigator: Kenneth J. Cohen
Contact: Kenneth J. Cohen Phone: 410-955-8804
Click HERE to send email to this center

Detroit, Michigan
Facility: Wayne State University/Karmanos Cancer Institute
Investigator: Zhihong J. Wang
Contact: Zhihong J. Wang Phone: 313-576-9363
Email not avaialable

Grand Rapids, Michigan
Facility: Helen DeVos Children's Hospital at Spectrum Health
Investigator: David S. Dickens
Contact: David S. Dickens Phone: 616-267-1925
Email not avaialable

Minneapolis, Minnesota
Facility: Children's Hospitals and Clinics of Minnesota - Minneapolis
Investigator: Bruce C. Bostrom
Contact: Bruce C. Bostrom Phone: 612-813-5193
Email not avaialable

Minneapolis, Minnesota
Facility: University of Minnesota Medical Center-Fairview
Investigator: Christopher L. Moertel
Contact: Christopher L. Moertel Phone: 612-624-2620
Email not avaialable

Rochester, Minnesota
Facility: Mayo Clinic
Investigator: Amulya A. Nageswara Rao
Contact: Amulya A. Nageswara Rao Phone: 507-538-7623
Email not avaialable

Jackson, Mississippi
Facility: University of Mississippi Medical Center
Investigator: Gail C. Megason
Contact: Gail C. Megason Phone: 601-815-6700
Email not avaialable

Kansas City, Missouri
Facility: The Childrens Mercy Hospital
Investigator: Maxine L. Hetherington
Contact: Maxine L. Hetherington Phone: 816-234-3265
Email not avaialable

Omaha, Nebraska
Facility: Children's Hospital and Medical Center of Omaha
Investigator: Minnie Abromowitch
Contact: Minnie Abromowitch Phone: 402-955-3949
Email not avaialable

Omaha, Nebraska
Facility: University of Nebraska Medical Center
Investigator: Minnie Abromowitch
Contact: Minnie Abromowitch Phone: 402-955-3949
Email not avaialable

Hackensack, New Jersey
Facility: Hackensack University Medical Center
Investigator: Michael B. Harris
Contact: Michael B. Harris Phone: 201-996-2879
Email not avaialable

Morristown, New Jersey
Facility: Morristown Memorial Hospital
Investigator: Steven L. Halpern
Contact: Steven L. Halpern Phone: 973-971-5900
Email not avaialable

New Brunswick, New Jersey
Facility: UMDNJ - Robert Wood Johnson University Hospital
Investigator: Richard A. Drachtman
Contact: Richard A. Drachtman Phone: 732-235-8675
Email not avaialable

Albuquerque, New Mexico
Facility: University of New Mexico
Investigator: Koh B. Boayue
Contact: Koh B. Boayue Phone: 505-272-6972
Email not avaialable

Bronx, New York
Facility: Montefiore Medical Center - Moses Campus
Investigator: Peter D. Cole
Contact: Peter D. Cole Phone: 718-904-2730
Click HERE to send email to this center

Buffalo, New York
Facility: Roswell Park Cancer Institute
Investigator: Martin L. Brecher
Contact: Martin L. Brecher Phone: 877-275-7724
Email not avaialable

Syracuse, New York
Facility: State University of New York Upstate Medical University
Investigator: Karol H. Kerr
Contact: Karol H. Kerr Phone: 315-464-5476
Email not avaialable

Valhalla, New York
Facility: New York Medical College
Investigator: Jessica C. Hochberg
Contact: Jessica C. Hochberg Phone: 914-594-3794
Email not avaialable

Akron, Ohio
Facility: Children's Hospital Medical Center of Akron
Investigator: Steven J. Kuerbitz
Contact: Steven J. Kuerbitz Phone: 330-543-3193
Email not avaialable

Cincinnati, Ohio
Facility: Cincinnati Children's Hospital Medical Center
Investigator: John P. Perentesis
Contact: John P. Perentesis Phone: 513-636-2799
Email not avaialable

Cleveland, Ohio
Facility: Rainbow Babies and Childrens Hospital
Investigator: Yousif (Joe) H. Matloub
Contact: Yousif (Joe) H. Matloub Phone: 216-844-5437
Email not avaialable

Columbus, Ohio
Facility: Nationwide Children's Hospital
Investigator: Mark A. Ranalli
Contact: Mark A. Ranalli Phone: 614-722-2708
Email not avaialable

Oklahoma City, Oklahoma
Facility: University of Oklahoma Health Sciences Center
Investigator: Rene Y. McNall-Knapp
Contact: Rene Y. McNall-Knapp Phone: 405-271-4272
Click HERE to send email to this center

Hershey, Pennsylvania
Facility: Penn State Hershey Children's Hospital
Investigator: Lisa M. McGregor
Contact: Lisa M. McGregor Phone: 717-531-3779
Click HERE to send email to this center

Pittsburgh, Pennsylvania
Facility: Children's Hospital of Pittsburgh of UPMC
Investigator: Regina I. Jakacki
Contact: Regina I. Jakacki Phone: 412-692-5573
Email not avaialable

Greenville, South Carolina
Facility: BI-LO Charities Children's Cancer Center
Investigator: Nichole L. Bryant
Contact: Nichole L. Bryant Phone: 864-241-6251
Email not avaialable

Dallas, Texas
Facility: Medical City Dallas Hospital
Investigator: Carl Lenarsky
Contact: Carl Lenarsky Phone: 972-566-5588
Email not avaialable

Fort Worth, Texas
Facility: Cook Children's Medical Center
Investigator: Mary Meaghan P. Granger
Contact: Mary Meaghan P. Granger Phone: 682-885-2103
Email not avaialable

Houston, Texas
Facility: Baylor College of Medicine
Investigator: Jack M. Su
Contact: Jack M. Su Phone: 713-798-1354
Click HERE to send email to this center

San Antonio, Texas
Facility: Methodist Children's Hospital of South Texas
Investigator: Jaime Estrada
Contact: Jaime Estrada Phone: 210-575-7000
Email not avaialable

Norfolk, Virginia
Facility: Childrens Hospital-King's Daughters
Investigator: Eric J. Lowe
Contact: Eric J. Lowe Phone: 757-668-7243
Email not avaialable

Seattle, Washington
Facility: Seattle Children's Hospital
Investigator: Douglas S. Hawkins
Contact: Douglas S. Hawkins Phone: 866-987-2000
Email not avaialable

Milwaukee, Wisconsin
Facility: Midwest Children's Cancer Center
Investigator: Sachin S. Jogal
Contact: Sachin S. Jogal Phone: 414-805-4380
Email not avaialable




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