Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients with Newly Diagnosed Ependymoma
Description
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.
Eligibility Criteria
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
Locations & Contacts
Alabama
Birmingham
Status: Active
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Arizona
Mesa
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Phoenix
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Arkansas
Little Rock
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California
Downey
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Phone: 510-891-3400
Duarte
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Loma Linda
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Los Angeles
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Madera
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San Diego
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Florida
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Georgia
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Augusta
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Savannah
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Hawaii
Honolulu
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Idaho
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Illinois
Chicago
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Maywood
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Oak Lawn
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Peoria
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Springfield
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Indiana
Indianapolis
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Phone: 800-248-1199
Status: Temporarily closed to accrual
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Iowa
Des Moines
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Iowa City
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Phone: 800-237-1225
Kentucky
Lexington
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Louisville
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Louisiana
New Orleans
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Phone: 504-703-8712
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Maine
Bangor
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Scarborough
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Maryland
Baltimore
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Massachusetts
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Michigan
Ann Arbor
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Detroit
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East Lansing
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Grand Rapids
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Kalamazoo
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Minnesota
Minneapolis
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Rochester
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Mississippi
Jackson
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Missouri
Columbia
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Kansas City
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Saint Louis
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Nebraska
Omaha
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Nevada
Las Vegas
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New Hampshire
Lebanon
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New Jersey
Hackensack
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Phone: 201-996-2879
Livingston
Status: Temporarily closed to accrual
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Morristown
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New Brunswick
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Phone: 732-235-8675
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Newark
Status: Temporarily closed to accrual
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Paterson
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New Mexico
Albuquerque
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New York
Albany
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Bronx
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Buffalo
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Mineola
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New Hyde Park
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New York
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Phone: 212-305-6361
Email: nr2616@cumc.columbia.edu
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Rochester
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Syracuse
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Valhalla
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North Carolina
Chapel Hill
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Charlotte
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Winston-Salem
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North Dakota
Fargo
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Ohio
Akron
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Cincinnati
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Cleveland
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Columbus
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Dayton
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Toledo
Status: Temporarily closed to accrual
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Email: ctsucontact@westat.com
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Oklahoma
Oklahoma City
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Oregon
Portland
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Pennsylvania
Allentown
Status: Temporarily closed to accrual
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Danville
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Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Hershey
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Philadelphia
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Email: helpdesk@childrensoncologygroup.org
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Pittsburgh
Status: Temporarily closed to accrual
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Rhode Island
Providence
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Phone: 401-444-1488
South Carolina
Charleston
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Phone: 843-792-9321
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Columbia
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Greenville
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South Dakota
Sioux Falls
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Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org
Tennessee
Chattanooga
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Knoxville
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Phone: 865-541-8266
Memphis
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Nashville
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Phone: 800-811-8480
Texas
Austin
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Corpus Christi
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Dallas
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Phone: 972-566-5588
Fort Worth
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Houston
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Phone: 713-798-1354
Email: burton@bcm.edu
Lubbock
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Status: Active
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San Antonio
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Status: Active
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Status: Active
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Phone: 210-450-3800
Email: phoresearchoffice@uthscsa.edu
Temple
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Phone: 254-724-5407
Utah
Salt Lake City
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Vermont
Burlington
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Phone: 802-656-8990
Virginia
Falls Church
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Phone: 703-208-6650
Email: Stephanie.VanBebber@inova.org
Norfolk
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Richmond
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Email: mwellons@vcu.edu
Roanoke
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Washington
Seattle
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Spokane
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Tacoma
Status: Active
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Phone: 253-968-0129
Email: mamcdci@amedd.army.mil
Status: Active
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Email: helpdesk@childrensoncologygroup.org
West Virginia
Charleston
Status: Active
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Phone: 304-388-9944
Morgantown
Status: Active
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Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu
Wisconsin
Green Bay
Status: Active
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Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Madison
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Marshfield
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Milwaukee
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Phone: 414-955-4727
Email: MACCCTO@mcw.edu
Alberta
Calgary
Status: Active
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Email: helpdesk@childrensoncologygroup.org
Edmonton
Status: Temporarily closed to accrual
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Phone: 780-407-6615
Email: val.taylor@albertahealthservices.ca
British Columbia
Vancouver
Status: Active
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Email: helpdesk@childrensoncologygroup.org
Manitoba
Winnipeg
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Phone: 866-561-1026
Email: ctu_web@cancercare.mb.ca
Newfoundland and Labrador
Saint John's
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Phone: 866-722-1126
Nova Scotia
Halifax
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Phone: 902-470-6767
Ontario
Hamilton
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Kingston
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Phone: 613-549-6666
Email: cc-clinicaltrials@kgh.kari.net
London
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Ottawa
Status: Active
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Toronto
Status: Active
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Phone: 416-813-7654ext2027
Email: jason.mcguire@sickkids.ca
Quebec
Montreal
Status: Active
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Phone: 514-345-4931
Status: Active
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Quebec
Status: Active
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Saskatchewan
Saskatoon
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Phone: 306-655-2914
Australia
Hunter Regional Mail Centre
Status: Active
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North Adelaide
Status: Active
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Parkville
Status: Temporarily closed to accrual
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Perth
Status: Active
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Randwick
Status: Active
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South Brisbane
Status: Active
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Westmead
Status: Active
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New Zealand
Christchurch
Status: Active
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Phone: 03 364 0640
Grafton
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Trial Objectives and Outline
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.
Trial Phase & Type
Treatment
Lead Organization
Lead Organization
Childrens Oncology Group
Principal Investigator
Amy Amundson Smith
Trial IDs
Secondary IDs NCI-2011-02029, COG-ACNS0831, CDR0000668560, 10-01676
Clinicaltrials.gov ID NCT01096368