HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 10
Updated:3/23/2019
Start Date:September 2015
End Date:September 2020
Contact:Megan Jaeger, MPH
Email:megan.jaeger@nationwidechildrens.org
Phone:614-722-3686

Use our guide to learn which trials are right for you!

HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue

This is a prospective randomized clinical trial, to determine whether dose-intensive tandem
Consolidation, in a randomized comparison with single cycle Consolidation, provides an
event-free survival (EFS) and overall survival (OS). The study population will be high-risk
patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with
central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study
will further determine whether the additional labor intensity (duration of hospitalizations
and short-term and long-term morbidities) associated with the tandem treatment is justified
by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation
regimen will produce a superior outcome compared to the single cycle Consolidation, given the
substantially higher dose intensity of the tandem regimen, without significant addition of
either short-term or long-term morbidities.

Due to the inferior response and event-free survival data of Regimens D and D2 on "Head Start
III" for all children with supratentorial embryonal tumors, in comparison with the published
data from "Head Start II" with Regimen A2 for metastatic patients, all such patients will
receive the "Head Start II" Induction Regimen A2, on "Head Start 4", for either three or five
cycles, depending upon whether or not they achieve complete remission by the end of Induction
cycle #3. They will then undergo randomization to either single cycle or three tandem cycles
of Consolidation marrow-ablative chemotherapy with AuHPCR.

Because of the unsatisfactory event-free survival for young children with
non-desmoplastic/extensive nodular medulloblastoma (predominantly non-Shh and non-Wnt
medulloblastoma subgroups) on Regimens D and D2 of "Head Start III", all these patients will
receive the "Head Start II" Induction Regimen A2 on ""Head Start 4"", for either three or
five cycles, depending upon whether or not they achieve complete remission by the end of
Induction cycle #3. They will then undergo randomization to either single cycle or three
tandem cycles of Consolidation marrow-ablative chemotherapy with AuHPCR.

Because of the excellent event-free and overall survival for young children with good risk
medullo-blastoma (Shh or Wnt subgroups) treated with up-front "Head Start" chemotherapy
strategies, such patients will undergo risk-tailored reduction of duration of Induction
therapy from five cycles to three cycles of the "Head Start II" Induction Regimen A2 on "Head
Start 4" for patients achieving a complete response to 3 cycles, followed, provided they are
also without evidence of residual tumor following recovery from Induction cycle #3. They will
NOT then undergo randomization, but will follow with a single cycle of Consolidation
marrow-ablative chemotherapy as in "Head Start" studies.

Inclusion Criteria:

- Patients 10 years of age at the time of definitive confirmatory eligible histologic or
cytologic diagnosis of eligible CNS tumor (brain or spinal cord)

- Patients may not have received irradiation or chemotherapy (except corticosteroids)

- Have histologically proven diagnosis of medulloblastoma or CNS embryonal tumors of the
brain or spinal cord

- Medulloblastoma

- Posterior fossa classic, desmoplastic or extensive nodular or anaplastic/large
cell medulloblastoma with appropriate and sufficient tumor material (FFPE or snap
frozen) for proposed assays: all stages, age less than 6 years at diagnosis

- Posterior fossa classic or anaplastic/large cell medulloblastoma with sufficient
tumor material (FFPE or snap frozen) for proposed assays: clinically high-stage
(neuraxis or extra-neural dissemination, M1-4), age greater than 6 years to less
than 10 years at diagnosis

- Posterior fossa medulloblastoma, those 6 years of age and above at diagnosis,
will only be eligible if they have evidence of neuraxis or extraneural
dissemination. Patients 6 years of age and above with low-stage (standard-risk,
M0) medulloblastoma will NOT be eligible for this study, irrespective of
molecular subgroup and extend of local resection

- CNS Embryonal Tumors:

- Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastoma, embryonal tumor with
multi-layered rosettes (ETMR, including embryonal tumor with abundant neuropil and
true rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified),
medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI1 intact) and CNS
embryonal tumor, not otherwise specified.

- Must commence Induction chemotherapy within 28 days of the most recent definitive
surgical procedure and within 21 days of the most recent neuro-imaging studies (MRI of
brain, performed with and without gadolinium contrast, and MRI of total spine,
performed with gadolinium contrast) and lumbar CSF cytological examination

- Patients must have adequate organ functions at the time of registration:

- Liver: bilirubin less than 1.5 mg/dL (except for patients with Gilbert's Syndrome
of indirect hyperbilirubinemia) and transaminases [SGPT or ALT, and SGOT or AST]
less than 2.5 (two and a half) times the upper limits of institutional normal.

- Renal: Creatinine clearance and/or glomerular filtration rate (GFR) greater than
or equal to 60 mL/min/1.73m² within 21 days of protocol therapy.

- Bone Marrow Function:

1. Peripheral absolute phagocyte count (APC) > 1000/ µL. APC = numbers of
banded neutrophils + segmented neutrophils + metamyelocytes + monocytes +
eosinophils Please note, if institution reports differential as a
percentage, then APC = [percentage of banded neutrophils + segmented
neutrophils+ metamyelocytes+monocytes+eosinophils] x total white cell count.

2. Platelet Count > 100,000/µL (transfusion independent)

3. Hemoglobin > 8 gm/dL (may have received RBC transfusions).

Exclusion Criteria:

- Patients older than 10 years of age at time of diagnosis

- Following diagnoses are not eligible for study enrollment: CNS atypical
teratoid/rhabdoid tumor (AT/RT); all ependymomas including anaplastic ependymomas of
the brain or spinal cord; all choroid plexus carcinomas; all high-grade glial and
glio-neuronal tumors; all primary CNS germ cell tumors; all primary CNS sarcomas; all
primary or metastatic CNS lymphomas and solid leukemic lesions (i.e., chloromas,
granulocytic sarcomas).

- Patients with unbiopsied diffuse intrinsic pontine tumors will NOT be eligible for
this study.
We found this trial at
45
sites
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Phone: 414-955-4170
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Phone: 330-543-8730
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
?
mi
from
Akron, OH
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-444-9532
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Phone: 216-844-3345
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Jonathan Finlay, MD
Phone: 614-722-3686
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Phone: 313-745-5515
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Girish Dhall, MD
Phone: 323-361-8147
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Phone: 615-322-5000
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Phone: 714-509-4348
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
?
mi
from
Orange, CA
Click here to add this to my saved trials
24 Sturtevant St
Orlando, Florida 32806
Phone: 321-841-8588
?
mi
from
Orlando, FL
Click here to add this to my saved trials
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 267-426-2285
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-615-2736
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Phone: 404-213-7777
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Phone: 720-777-8314
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Phone: 410-614-5055
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Birmingham, Alabama 35233
Phone: 205-638-9285
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-4386
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Charlotte, North Carolina 28204
Phone: 704-381-9900
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Fountain Valley, California 92708
Phone: 562-933-8626
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
1600 Southwest Archer Road
Gainesville, Florida 32610
Phone: 312-294-8347
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
Phone: 616-267-1925
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
30 Prospect Avenue
Hackensack, New Jersey 07601
Phone: 551-996-5437
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
600 Hempstead Turnpike
Hempstead, New York 11549
Phone: 718-470-3460
?
mi
from
Hempstead, NY
Click here to add this to my saved trials
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-8521
Phone: 717-531-6012
Penn State Hershey Children's Hospital Penn State Milton S. Hershey Medical Center, Penn State College...
?
mi
from
Hershey, PA
Click here to add this to my saved trials
705 Riley Hospital Drive
Indianapolis, Indiana 46202
Phone: 317-944-8784
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 19803
Phone: 904-697-3793
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Phone: 501-364-1494
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Phone: 909-558-4076
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
Los Angeles, California 90095
Phone: 310-825-6708
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
Phone: 502-852-8450
?
mi
from
Louisville, KY
Click here to add this to my saved trials
1675 Highland Avenue
Madison, Wisconsin 53792
Phone: 608-263-6200
?
mi
from
Madison, WI
Click here to add this to my saved trials
Miami, Florida 33155
Phone: 305-662-8360
?
mi
from
Miami, FL
Click here to add this to my saved trials
2450 Riverside Avenue
Minneapolis, Minnesota 55454
Phone: 614-625-3229
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
Phone: 612-813-6835
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
New York, New York 10016
Phone: 212-263-9913
?
mi
from
New York, NY
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 212-639-6410
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10032
Phone: 212-305-5808
?
mi
from
New York, NY
Click here to add this to my saved trials
747 52nd Street
Oakland, California 94609
Phone: 510-428-3272
?
mi
from
Oakland, CA
Click here to add this to my saved trials
1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phone: 602-933-0920
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Saint Petersburg, Florida 33701
Phone: 727-767-4176
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Salt Lake City, Utah 84143
Phone: 801-662-1000
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Syracuse, New York 13210
Phone: 315-464-5294
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Vancouver, British Columbia
Phone: 604-875-2345
?
mi
from
Vancouver,
Click here to add this to my saved trials
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Phone: 202-476-2800
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
?
mi
from
Washington,
Click here to add this to my saved trials
1600 Rockland Road
Wilmington, Delaware 19803
Phone: 302-651-5500
?
mi
from
Wilmington, DE
Click here to add this to my saved trials