Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed, Non-metastatic Desmoplastic Medulloblastoma



Status:Active, not recruiting
Conditions:Brain Cancer, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Oncology
Healthy:No
Age Range:Any
Updated:4/6/2019
Start Date:December 24, 2013

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A Phase II Study for the Treatment of Non-metastatic Nodular Desmoplastic Medulloblastoma in Children Less Than 4 Years of Age

This phase II trial studies how well combination chemotherapy works in treating younger
patients with newly diagnosed, non-metastatic desmoplastic medulloblastoma. Drugs used in
chemotherapy, such as vincristine sulfate, cyclophosphamide, methotrexate, etoposide, and
carboplatin, 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.

PRIMARY OBJECTIVES:

I. Estimate of the progression free survival (PFS) distribution for patients 0-<4 years of
age with M0 desmoplastic medulloblastoma (nodular desmoplastic or medulloblastoma with
extensive nodularity) treated with the modified HIT SKK regimen (excluding the use of
intraventricular methotrexate).

OTHER PRE-SPECIFIED OBJECTIVES:

I. Evaluate the feasibility of a rapid central pathology screening review for treatment
allocation according to histology and assess agreement between institutional and central
pathology review diagnoses as well as among central pathology review diagnoses.

II. Prospectively evaluate the molecular profile of nodular desmoplastic (ND)/medulloblastoma
with extensive nodularity (MBEN) medulloblastoma in young children.

III. Monitor and describe the neurocognitive and adaptive functioning of young children with
ND/MBEN medulloblastoma treated on this protocol using the ALTE07C1 protocol.

OUTLINE:

INDUCTION THERAPY: Patients receive vincristine sulfate intravenously (IV) over 1 minute or
infused via minibag on days 1, 15, and 29; cyclophosphamide IV over 1 hour on days 1-3;
methotrexate IV over 24 hours on days 15 and 29; etoposide IV over 60-120 minutes on days
43-45; and carboplatin IV over 1 hour on days 43-45. Treatment repeats every 63 days for 3
courses in the absence of disease progression or unacceptable toxicity.

CONTINUATION THERAPY: Patients receive vincristine sulfate IV over 1 minute or infused via
minibag on day 1, cyclophosphamide IV over 1 hour on days 1-3, etoposide IV over 60-120
minutes on days 21-23, and carboplatin IV over 1 hour on days 21-23. Treatment repeats every
42 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3, 6, 9, 12, 16, 20, 24, 36,
48, 60, and 72 months.

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 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:

- 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 preferably 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
We found this trial at
159
sites
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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4900 Mueller Boulevard
Austin, Texas 78723
(512) 324-0000
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Principal Investigator: Alyssa T. Reddy
Phone: 205-934-0309
Children's Hospital of Alabama Children
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Martin L. Brecher
Phone: 877-275-7724
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: John P. Perentesis
Phone: 513-636-2799
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Principal Investigator: Yousif (Joe) H. Matloub
Phone: 216-844-5437
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Mark A. Ranalli
Phone: 614-722-2708
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Principal Investigator: Carl Lenarsky
Phone: 972-566-5588
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1200 Pleasant Street
Des Moines, Iowa 50309
(515) 241-KIDS
Principal Investigator: Wendy L. Woods-Swafford
Phone: 515-241-6729
Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
616.391.9000
Principal Investigator: David S. Dickens
Phone: 616-267-1925
Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Principal Investigator: Michael S. Isakoff
Phone: 860-545-9981
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Gail C. Megason
Phone: 601-815-6700
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Principal Investigator: Eric J. Lowe
Phone: 757-668-7243
Children's Hospital of The King's Daughters Children
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747 52nd St
Oakland, California 94609
(510) 428-3000
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Principal Investigator: Violet Shen
Phone: 714-997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Principal Investigator: Jeffrey H. Schwartz
Phone: 904-697-3529
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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530 Northeast Glen Oak Avenue
Peoria, Illinois 61603
(309) 624-4945
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South 34th Street
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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7700 Floyd Curl Dr
San Antonio, Texas 78229
(210) 575-7000
Principal Investigator: Jaime Estrada
Phone: 210-575-7000
Methodist Children's Hospital of South Texas Methodist Children
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
Principal Investigator: Jessica C. Hochberg
Phone: 914-594-3794
New York Medical College The College was founded in 1860 by a group of New...
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Principal Investigator: Christopher N. Frantz
Phone: 302-651-5755
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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Akron, Ohio 44308
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Albany, New York 12208
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1540 East Hospital Drive
Ann Arbor, Michigan 48109
(877) 475-6688
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Asheville, North Carolina 28801
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Atlanta, Georgia 30322
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Augusta, Georgia 30912
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13123 E 16th Ave
Aurora, Colorado 80045
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2401 W Belvedere Ave
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401 North Broadway
Baltimore, Maryland 21287
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489 State St
Bangor, Maine 04401
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
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100 E Idaho St
Boise, Idaho 83712
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Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Bronx, New York 10467
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Chattanooga, Tennessee 37403
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Chicago, Illinois 60614
Principal Investigator: Stewart Goldman
Phone: 773-880-4562
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Columbia, Missouri 65201
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
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100 North Academy Avenue
Danville, Pennsylvania 17822
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Detroit, Michigan 48236
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Principal Investigator: Zhihong J. Wang
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Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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9333 Imperial Highway
Downey, California 90242
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801 Broadway North
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Principal Investigator: Mary Meaghan P. Granger
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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1600 Southwest Archer Road
Gainesville, Florida 32610
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
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BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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Hunter Regional Mail Centre, New South Wales
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
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Indianapolis, Indiana 46260
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Jacksonville, Florida 32207
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Kansas City, Missouri 64108
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2018 W Clinch Ave
Knoxville, Tennessee 37916
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Albert Kheradpour
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Marshfield, Wisconsin 54449
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
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Miami, Florida 33155
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
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259 1st Street
Mineola, New York 11501
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Minneapolis, Minnesota 55455
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2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
Principal Investigator: Bruce C. Bostrom
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