Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma



Status:Recruiting
Conditions:Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 20
Updated:2/24/2019
Start Date:March 29, 2010

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Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years

This partially randomized phase III trial is studying maintenance chemotherapy to see how
well it works compared to observation following induction chemotherapy and radiation therapy
in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such
as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, 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 more than one drug
(combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy
x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of
radiation directly to the tumor may kill more tumor cells and cause less damage to normal
tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow
doctors to save the part of the body where the cancer started.

PRIMARY OBJECTIVES:

I. To determine the event free survival (EFS) and overall survival (OS) of children with
completely resected ependymoma treated with post-operative conformal radiation therapy (cRT)
and then randomized to receive or not receive four cycles of post radiation maintenance
chemotherapy (vincristine sulfate [vincristine] cisplatin, etoposide and cyclophosphamide
[VCEC]).

SECONDARY OBJECTIVES:

I. To estimate the EFS and OS of children with incompletely resected ependymoma who are
unable to achieve a complete response (CR) by post-operative induction chemotherapy or by
second surgery who will then be non-randomly assigned to cRT followed by four cycles of
maintenance chemotherapy (VCEC).

II. To further evaluate the EFS and OS of children with supratentorial classic ependymoma who
achieve a complete resection at first or second resection OR children who achieve a CR to
short course induction chemotherapy following first surgery.

III. To evaluate whether the addition of maintenance chemotherapy post-radiation therapy
contributes to neurobehavioral morbidity and reduced functional outcomes over time, compared
to patients treated with radiation therapy followed by observation alone.

IV. To examine differences in neurobehavioral outcomes and quality of life of children
treated with proton beam radiation therapy compared to children treated with conventional
radiation delivery techniques.

V. To evaluate biologic prognostic factors in childhood ependymoma by utilizing genomic
profiles via comparative genomic hybridization (CGH), single-nucleotide polymorphism arrays,
and microarray gene expression profiling analysis on initial tumor samples and correlating
this data with clinical outcome.

VI. Explore prognostic molecular signatures and genomic alterations in ependymomas.

VII. Evaluate prognostic immune-function gene expression in ependymomas. VIII. Build upon the
data derived from COG-ACNS0121 to develop genotypically based classification signatures and
to correlate these to World Health Organization (WHO) grade, location, extent of resection,
treatment, EFS, and OS.

IX. To evaluate telomere maintenance as a prognostic marker.

OUTLINE: Patients are assigned to Arm I or randomized to Arms II or III.

Arm I: Patients receive vincristine sulfate intravenously (IV) over 1 minute on days 1 and 8
of courses 1 and 2, carboplatin IV over 15-60 minutes on day 1 of courses 1 and 2, and
cyclophosphamide IV over 30-60 minutes on days 1-2 of course 1 only. Patients also receive
etoposide IV over 60-120 minutes on days 1-3 of course 2 only. Course 1 continues for 3 weeks
and course 2 continues for 4 weeks in the absence of disease progression or unacceptable
toxicity. Patients with complete response are randomized to Arm II or III. Patients achieving
stable disease, partial response, or locally progressive disease and who are deemed
potentially resectable undergo surgery within 15 days after completion of induction
chemotherapy. Patients with sub total resection are assigned to Arm II. Patients with gross
total resection undergo observation.

ARM II: Patients undergo conformal radiotherapy over 6-7 weeks. Patients then receive
vincristine sulfate IV on days 1, 8, and 15 of courses 1-3 only, etoposide IV over 60-120
minutes on days 1-3, cisplatin IV over 1-8 hours on day 1, and cyclophosphamide IV over 30-60
minutes on days 2-3. Treatment repeats every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity.

ARM III: Patients undergo conformal radiotherapy over 6-7 weeks and then undergo observation.

After completion of study therapy, patients are followed up every 4 months for 5 years, and
then annually thereafter.

Inclusion Criteria:

- Patients must be newly diagnosed with histologically confirmed intracranial
ependymoma; patients with classic ependymoma (WHO II) or anaplastic ependymoma (WHO
III) are eligible, as are various subtypes described as clear cell, papillary,
cellular or a combination of the above

- There is no minimum performance level; children with ependymoma may suffer neurologic
sequelae as a result of their tumor or surgical measures taken to establish a
diagnosis and resect the tumor; in the majority of cases, there is neurologic
recovery; neurologic recovery is not likely to be impeded by protocol therapy

- All patients and/or their parents or legal guardians must sign a written informed
consent

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

Exclusion Criteria:

- Patients with evidence of metastatic disease will be excluded; any evidence of
non-contiguous spread beyond the primary site as determined by pre or post-operative
magnetic resonance (MR) imaging of brain, pre or post-operative MR imaging of the
spine, and post-operative cerebrospinal fluid (CSF) cytology obtained from the lumbar
CSF space (the requirement for lumbar CSF examination may be waived if deemed to be
medically contraindicated); CSF cytology from a ventriculostomy or permanent
ventriculoperitoneal (VP) shunt that reveals the presence of tumor cells is indicative
of metastatic disease

- Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma,
subependymoma, ependymoblastoma, or mixed glioma are NOT eligible

- No prior treatment other than surgical intervention and corticosteroids; patients are
allowed to have had more than one attempt at resection prior to enrollment

- Pregnant female patients are not eligible for this study

- Post-menarchal females may not participate unless a pregnancy test with a negative
result has been obtained

- Males and females of reproductive potential may not participate unless they have
agreed to use an effective contraceptive method

- Lactating females may not participate unless they have agreed not to breastfeed a
child while on this study
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9333 Imperial Highway
Downey, California 90242
Principal Investigator: Robert M. Cooper
Phone: 510-891-3400
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Downey, CA
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East Lansing, Michigan 48824
Principal Investigator: Aghiad Chamdin
Phone: 517-975-9547
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East Lansing, MI
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801 Broadway North
Fargo, North Dakota 58122
Principal Investigator: Samuel O. Anim
Phone: 800-437-4010
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from
Fargo, ND
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Principal Investigator: Hector M. Rodriguez-Cortes
Phone: 954-355-5346
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Fort Lauderdale, FL
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Fort Myers, Florida 33908
Principal Investigator: Emad K. Salman
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Fort Myers, FL
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Principal Investigator: Jeffrey C. Murray
Phone: 682-885-2103
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Fort Worth, TX
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1600 Southwest Archer Road
Gainesville, Florida 32610
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Gainesville, FL
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835 S Van Buren St
Green Bay, Wisconsin 54301
Principal Investigator: Catherine A. Long
Phone: 920-433-8889
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Green Bay, WI
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
Principal Investigator: Nichole L. Bryant
Phone: 864-241-6251
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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from
Greenville, SC
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Greenville, South Carolina 29605
Principal Investigator: Nichole L. Bryant
Phone: 864-241-6251
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Greenville, SC
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Derek R. Hanson
Phone: 201-996-2879
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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Hershey, Pennsylvania 17033
Principal Investigator: Lisa M. McGregor
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Hershey, PA
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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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Honolulu, HI
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Houston, Texas 77030
Principal Investigator: Murali M. Chintagumpala
Phone: 713-798-1354
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Houston, TX
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Hunter Regional Mail Centre, New South Wales
Principal Investigator: Bhavna Padhye
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Hunter Regional Mail Centre,
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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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Indianapolis, IN
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Iowa City, Iowa 52242
Principal Investigator: Mariko Sato
Phone: 800-237-1225
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Iowa City, IA
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Jacksonville, Florida 32207
Principal Investigator: Andrew W. Walter
Phone: 904-697-3529
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Jacksonville, FL
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Kansas City, Missouri 64108
Principal Investigator: Keith J. August
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Kansas City, MO
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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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Knoxville, TN
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Las Vegas, Nevada 89109
Principal Investigator: Nik F. Nik Abdul Rashid
Phone: 702-384-0013
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Las Vegas, NV
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Las Vegas, Nevada 89135
Principal Investigator: Nik F. Nik Abdul Rashid
Phone: 702-384-0013
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Las Vegas, NV
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Las Vegas, Nevada 89144
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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Las Vegas, NV
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