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



Status:Active, not recruiting
Healthy:No
Age Range:Any
Updated:1/11/2017
Start Date:December 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 or by stopping them from dividing.

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).

SECONDARY 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 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
We found this trial at
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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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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
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Children's Hospital of Alabama Children
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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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
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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
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
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Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1200 Pleasant Street
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(515) 241-KIDS
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100 Michigan Street Northeast
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1200 Moursund Street
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2500 N State St
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2401 Gillham Rd
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(816) 234-3000
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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231 E Chestnut St
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601 Children's Lane
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Children's Hospital of The King's Daughters Children
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1201 W La Veta Ave
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5153 North 9th Avenue
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530 Northeast Glen Oak Avenue
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2279 45th Street
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7700 Floyd Curl Dr
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40 Sunshine Cottage Road
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1600 Rockland Road
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Chicago, Illinois 60614
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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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4760 Sunset Blvd
Downey, California 90027
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
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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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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
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30 Prospect Ave
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(201) 996-2000
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500 University Dr
Hershey, Pennsylvania 17033
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
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Jacksonville, Florida 32207
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11234 Anderson St
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Milwaukee, Wisconsin 53226
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2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
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2450 Riverside Ave
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100 Madison Ave
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One Robert Wood Johnson Place
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New Orleans, Louisiana 70121
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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8200 Dodge St
Omaha, Nebraska 68114
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Emile St
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Orlando, Florida 32806
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13535 Nemours Parkway
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(407) 567-4000
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4800 Sand Point Way NE
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(206) 987-2000
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3001 W Dr Martin Luther King Jr Blvd
Tampa, Florida 33607
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111 Michigan Ave NW
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