Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Biomarker/Laboratory analysis, Treatment	Active	30 and under	NCI	COG-ANBL0532 ANBL0532, NCT00567567

Objectives

Primary

1. To improve the 3-year event-free survival (EFS) rate of high-risk neuroblastoma patients through treatment with a tandem consolidation of thiotepa/cyclophosphamide followed by carboplatin/etoposide/melphalan (CEM) as compared to single CEM consolidation.
2. To improve the rate of end-induction complete response and very good partial response, compared to historical controls, by use of a topotecan-containing induction regimen.
3. To improve the 3-year local control rate, compared to historical controls, by increasing the local dose of radiation to the residual primary tumor for patients with less than a gross total resection.

Secondary

1. To evaluate the pharmacogenetic relationship of cyclophosphamide metabolizing enzymes (i.e., CYP2B6, CYP2C9, and GSTA1 genotypes) with toxicity and response following dose-intensive cyclophosphamide and topotecan induction chemotherapy.
2. To determine if resection completeness is predictive of local control rate or EFS rate in patients with high-risk neuroblastoma.
3. To prospectively describe the complications related to efforts at local control (i.e., surgery and radiotherapy) in patients with high-risk neuroblastoma.
4. To describe the neurologic outcome of patients with paraspinal primary neuroblastoma tumors.
5. To determine the variability of isotretinoin pharmacokinetics (PKs) and relationship to pharmacogenomic parameters.
6. To determine if isotretinoin PK levels are predictive of the EFS rate or associated with systemic toxicity following isotretinoin.
7. To determine if pharmacogenomic variations are predictive of the EFS rate or associated with systemic toxicity following isotretinoin.
8. To evaluate total topotecan PKs and correlate with patient specific data for use in an ongoing topotecan population PK analysis.
9. To evaluate the presence and function of T cells capable of recognizing neuroblastoma by assessing the following: if T cells recognizing the neuroblastoma antigen, survivin, circulate at diagnosis; if these T cells can be expanded using autologous antigen presenting cells (APCs); if these T cells will kill neuroblastoma cells as detected in functional assays; and if the presence and activity of anti-neuroblastoma immunity is decreased by stem cell transplantation.
10. To characterize the recovery of T-cell numbers after myeloablative consolidation and hematopoietic stem cell transplantation (HSCT) and to assess the impact of tandem myeloablative consolidation on T-cell recovery.
11. To characterize minimal residual disease burden using RT-PCR evaluation of a panel of neuroblastoma specific transcripts in patient bone marrow and peripheral blood following induction chemotherapy and after single versus tandem myeloablative chemotherapy and to evaluate impact on EFS.
12. To evaluate the EFS and overall survival of patients nonrandomly assigned to treatment with single myeloablative transplant (Arm A).

Entry Criteria

Disease Characteristics:

• Diagnosis of neuroblastoma or ganglioneuroblastoma by histology or as evidenced by the presence of clumps of tumor cells in bone marrow and elevated catecholamine metabolites in urine meeting any of the following criteria:
  • Patients with newly diagnosed neuroblastoma with International Neuroblastoma Staging System (INSS) stage 4 disease are eligible with the following:
    • MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
    • Age > 18 months (i.e., > 547 days) regardless of biologic features
    • Age 12-18 months (i.e., 365-547 days) with none of the following three favorable biologic features (i.e., non-amplified MYCN, favorable pathology, and DNA index > 1)
  • Patients with newly diagnosed neuroblastoma with INSS stage 3 are eligible with the following:
    • MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
    • Age > 18 months (i.e., > 547 days) with unfavorable pathology, regardless of MYCN status
  • Patients with newly diagnosed INSS stage 2a or 2b with MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
  • Patients with newly diagnosed INSS stage 4s with MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features
  • Patients ≥ 365 days initially diagnosed with INSS stage 1, 2, or 4S and who progressed to a stage 4 without interval chemotherapy
    • Must have been enrolled on COG-ANBL00B1

Prior/Concurrent Therapy:

• No prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease
• No more than one course of chemotherapy per low- or intermediate-risk neuroblastoma therapy prior to determination of MYCN amplification and histology

Patient Characteristics:

• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70mL/min OR 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
  • 6 to < 10 years: 1 mg/dL
  • 10 to < 13 years: 1.2 mg/dL
  • 10 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)
  • ≥ 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
• AST or ALT < 10 times ULN for age
• Not pregnant or nursing
• Negative pregnancy test
• Shortening fraction ≥ 27% by ECHO OR LVEF ≥ 50% by radionuclide angiogram
• No known contraindication (e.g., size, weight or physical condition) to peripheral blood stem cell collection

Expected Enrollment

Outcomes

Event-free survival rate
Response after induction therapy
Incidence rate of local recurrence

Duration of ≥ grade 3 neutropenia during course one
Duration of ≥ grade 3 thrombocytopenia during course one
Response rate after two courses of induction therapy

Outline

This is a multicenter study.

• Induction chemotherapy:
  • Courses 1 and 2: Patients receive cyclophosphamide IV over 30 minutes and topotecan hydrochloride IV over 30 minutes on days 1-5 and filgrastim (G-CSF) subcutaneously (SC) or IV beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. Patients undergo peripheral blood stem cell (PBSC) mobilization and harvest after course 2.
  • Courses 3 and 5: Patients receive cisplatin IV over 1 hour on days 1-4, etoposide IV over 1 hour on days 1-3, and G-CSF SC or IV beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. Patients undergo surgical resection of soft tissue disease after course 5 (or after course 6 if medically necessary).
  • Courses 4 and 6: Patients receive cyclophosphamide IV over 6 hours on days 1-2, doxorubicin hydrochloride IV over 24 hours on days 1-3, vincristine IV on days 1-3, and G-CSF SC or IV beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses.

Patients are then stratified by initial stage of disease and MYCN status, biologic characteristics, and response to induction chemotherapy (complete response/very good partial response vs partial response vs mixed response/no response). Patients are randomized to 1 of 2 arms. Patients 12–18 months old (i.e., 365-547 days) with stage IV, MYCN nonamplified tumor with unfavorable histopathology or diploid DNA content or with indeterminant histology or ploidy AND patients who are > 547 days of age with stage III, MYCN nonamplified tumor AND unfavorable histopathology or indeterminant histology will be nonrandomly assigned to Arm A. Patients begin consolidation chemotherapy no later than 8 weeks after the start of induction course 6.

• Consolidation therapy:
  • Arm A (single myeloablative consolidation): Patients receive melphalan IV over 15-30 minutes on days -7 to -5, etoposide IV over 24 hours and carboplatin IV over 24 hours on days -7 to -4, and G-CSF SC or IV beginning on day 0 and continuing until blood counts recover. Patients undergo PBSC reinfusion on day 0.
  • Arm B (tandem myeloablative consolidation): Patients receive thiotepa IV over 2 hours on days -7 to -5, cyclophosphamide IV over 1 hour on days -5 to -2, and G-CSF SC or IV beginning on day 0 and continuing until blood counts recover. Patients undergo PBSC reinfusion on day 0. Following clinical recovery from initial myeloablative therapy, patients also receive melphalan, etoposide, and carboplatin as in Arm A. Patients undergo PBSC reinfusion on day 0.
• Radiotherapy: Patients undergo radiotherapy to primary site of disease as well as to MIBG-avid sites seen at pre-transplantation (i.e., end-induction) evaluation between 28-42 days post-transplant. Additional radiotherapy is administered to residual tumor at primary site.
• Maintenance therapy: Patients are encouraged to enroll onto COG-ANBL0032 following assessment of tumor response after completion of the consolidation phase and radiotherapy. Beginning on day 60 post-transplantation patients receive oral isotretinoin twice daily on days 1-14. Treatment repeats every 28 days for up to 6 months in the absence of disease progression or unacceptable toxicity.

Patients undergo blood and tissue sample collection periodically for the following analyses: correlation between peak serum concentration level and the existence of polymorphisms, event-free survival, and toxicity rates; pharmacogenomics for UGT1A1, UGT2B7, CYP2C8 and CYP3A7 alleles; topotecan systemic clearance; survivin-specific cytotoxic T-lymphocytes (CTLs) detected using peptide/MHC tetramers in HLA-A2+ patients; IFN-gamma production in ELISPOT assays to antigen-presenting cells (APCs) loaded with tumor RNA, survivin RNA, or control RNA; response of APC-stimulated CTL response to neuroblastoma cells; rate of T cell recovery; and proportion of patients with neuroblastoma detected in bone marrow and peripheral blood using RT-PCR.

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Julie Park, MD, Protocol chair		Ph: 206-987-2106

U.S.A.
Alabama
	Birmingham
	UAB Comprehensive Cancer Center
		Clinical Trials Office - UAB Comprehensive Cancer Center	Ph:  205-934-0309
	Mobile
	University of South Alabama Mitchell Cancer Institute
		Felicia Wilson	Ph:  251-405-5115
Arizona
	Phoenix
	Phoenix Children's Hospital
		Jessica Boklan	Ph:  602-546-0920
	Tucson
	Arizona Cancer Center at University of Arizona Health Sciences Center
		Clinical Trials Office - Arizona Cancer Center at University of Arizona Health Sciences Center	Ph:  520-626-9008
Arkansas
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Ph:  501-686-8274
California
	Downey
	Southern California Permanente Medical Group
		Robert Cooper	Ph:  323-783-5307
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Center	Ph:  800-826-4673
			Email: becomingapatient@coh.org
	Loma Linda
	Loma Linda University Cancer Institute at Loma Linda University Medical Center
		Clinical Trials Office - Loma Linda University Cancer Institute	Ph:  909-558-3375
	Long Beach
	Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
		Jerry Finklestein	Ph:  562-492-1062
	Los Angeles
	Childrens Hospital Los Angeles
		Leo Mascarenhas	Ph:  323-361-2529
	Jonsson Comprehensive Cancer Center at UCLA
		Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA	Ph:  888-798-0719
	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
		Carole Hurvitz	Ph:  310-423-4423
	Madera
	Children's Hospital Central California
		Vonda Crouse	Ph:  559-353-5480
	Oakland
	Children's Hospital and Research Center Oakland
		Clinical Trial Office - Children's Hospital and Research Center Oakland	Ph:  510-450-7600
	Sacramento
	Kaiser Permanente Medical Center - Oakland
		Vincent Kiley	Ph:  916-474-2326
	San Diego
	Rady Children's Hospital - San Diego
		Clinical Trials Office - Rady Children's Hospital - San Diego	Ph:  858-966-5934
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222
	Stanford
	Stanford Cancer Center
		Clinical Trials Office - Stanford Cancer Center	Ph:  650-498-7061
			Email: cctoffice@stanford.edu
Colorado
	Aurora
	Children's Hospital Center for Cancer and Blood Disorders
		Kelly Maloney	Ph:  720-777-6673
	Denver
	Presbyterian - St. Luke's Medical Center
		Clinical Trials Office - Presbyterian - St. Luke's Medical Center	Ph:  303-839-6000
Connecticut
	Farmington
	Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
		Clinical Trials Office - Carole and Ray Neag Comprehensive Cancer Center	Ph:  800-579-7822
Delaware
	Wilmington
	Alfred I. duPont Hospital for Children
		Clinical Trials Office - Alfred I. duPont Hospital for Children	Ph:  302-651-5755
District of Columbia
	Washington
	Children's National Medical Center
		Clinical Trials Office - Children's National Medical Center	Ph:  202-884-2549
	Walter Reed Army Medical Center
		Clinical Trials Office - Walter Reed Army Medical Center	Ph:  202-782-7840
Florida
	Fort Lauderdale
	Broward General Medical Center Cancer Center
		Clinical Trials Office - Broward General Medical Center Cancer Center	Ph:  954-355-5346
	Fort Myers
	Lee Cancer Care of Lee Memorial Health System
		Clinical Trials Office - Lee Cancer Care of Lee Memorial Health System	Ph:  877-680-0008
	Gainesville
	University of Florida Shands Cancer Center
		Clinical Trials Office - University of Florida Shands Cancer Center	Ph:  888-254-7581
	Hollywood
	Memorial Cancer Institute at Memorial Regional Hospital
		Clinical Trials Office - Memorial Cancer Institute	Ph:  954-985-3443
	Jacksonville
	Nemours Children's Clinic
		Eric Sandler	Ph:  904-697-3793
	Miami
	Miami Children's Hospital
		Enrique Escalon	Ph:  305-662-8360x4960
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service	Ph:  866-574-5124
			Email: Sylvester@emergingmed.com
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clinical Trials Office - Florida Hospital Cancer Institute	Ph:  407-303-5623
	Nemours Children's Clinic - Orlando
		Paul Gordon	Ph:  407-650-7330
	Pensacola
	Sacred Heart Cancer Center at Sacred Heart Hospital
		Clinical Trials Office - Sacred Heart Cancer Center	Ph:  850-416-4611
	St. Petersburg
	All Children's Hospital
		Gregory Hale	Ph:  727-767-4176
	Tampa
	St. Joseph's Cancer Institute at St. Joseph's Hospital
		Clinical Trials Office - St. Joseph's Cancer Institute	Ph:  800-882-4123
	West Palm Beach
	Kaplan Cancer Center at St. Mary's Medical Center
		Narayana Gowda	Ph:  561-844-6363
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Howard Katzenstein	Ph:  404-785-0853
	Augusta
	MBCCOP - Medical College of Georgia Cancer Center
		Colleen McDonough	Ph:  706-721-3626
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute	Ph:  912-350-8568
Illinois
	Chicago
	Children's Memorial Hospital - Chicago
		Stewart Goldman	Ph:  773-880-3270
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	University of Illinois Cancer Center
		Clinical Trial Office - University of Illinois Cancer Center	Ph:  312-355-3046
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
Indiana
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Clinical Trials Office - Indiana University Cancer Center	Ph:  317-274-2552
	St. Vincent Indianapolis Hospital
		Clinical Trials Office - St. Vincent Indianapolis Hospital	Ph:  317-338-2194
Iowa
	Des Moines
	Blank Children's Hospital
		Clinical Trials Office - Blank Children's Hospital	Ph:  515-241-6729
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Kansas
	Kansas City
	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
		Clinical Trials Office - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Ph:  913-588-4709
Kentucky
	Lexington
	Lucille P. Markey Cancer Center at University of Kentucky
		Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center	Ph:  859-257-3379
	Louisville
	Kosair Children's Hospital
		Clinical Trials Office - Kosair Children's Hospital	Ph:  502-629-5500
			Email: CancerResource@nortonhealthcare.org
Louisiana
	Alexandria
	Tulane Cancer Center Office of Clinical Research
		Clinical Trials Office - Tulane Cancer Center	Ph:  504-988-6121
Maryland
	Baltimore
	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
		Joseph Wiley	Ph:  410-601-5864
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu
Massachusetts
	Boston
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		Suzanne Shusterman	Ph:  617-632-4901
	Floating Hospital for Children at Tufts - New England Medical Center
		Cynthia Kretschmar	Ph:  617-636-5535
	Worcester
	UMASS Memorial Cancer Center - University Campus
		Christopher Keuker	Ph:  508-856-4225
Michigan
	Ann Arbor
	C.S. Mott Children's Hospital at University of Michigan Medical Center
		Clinical Trials Office - C.S. Mott Children's Hospital	Ph:  1-800-865-1125
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
	Flint
	Hurley Medical Center
		Clinical Trials Office - Hurley Medical Center	Ph:  810-762-8057
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		David Dickens	Ph:  616-391-2086
	Grosse Pointe Woods
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center	Ph:  313-343-3166
	Kalamazoo
	CCOP - Kalamazoo
		Leonard Mattano, Jr.	Ph:  269-341-6350
	Lansing
	Breslin Cancer Center at Ingham Regional Medical Center
		Clinical Trials Office - Breslin Cancer Center at Ingham Regional Medical Center	Ph:  517-334-2765
Minnesota
	Minneapolis
	Children's Hospitals and Clinics of Minnesota - Minneapolis
		Clinical Trials Office - Children's Hospitals and Clinics of Minnesota	Ph:  612-813-5193
	Masonic Cancer Center at University of Minnesota
		Clinical Trials Office - Masonic Cancer Center at University of Minnesota	Ph:  612-624-2620
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Gail Megason	Ph:  601-984-5220
Missouri
	Kansas City
	Children's Mercy Hospital
		Maxine Hetherington	Ph:  816-234-3265
	St. Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Robert Hayashi	Ph:  314-454-4118
Nebraska
	Omaha
	Children's Hospital
		Minnie Abromowitch	Ph:  402-955-3950
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Ph:  800-999-5465
Nevada
	Las Vegas
		Jonathan Bernstein	Ph:  702-732-1493
	CCOP - Nevada Cancer Research Foundation
		Jonathan Bernstein	Ph:  702-732-0971
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Clinical Trials Office - Norris Cotton Cancer Center	Ph:  603-650-7609
			Email: cancerhelp@dartmouth.edu
New Jersey
	Hackensack
	Hackensack University Medical Center Cancer Center
		Clinical Trials Office - Hackensack University Medical Center Cancer Center	Ph:  201-996-2879
	Morristown
	Overlook Hospital
		Hazem Mahmoud	Ph:  973-971-6720
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Clinical Trials Office - Cancer Institute of New Jersey	Ph:  732-235-8675
	Saint Peter's University Hospital
		Douglas Cipkala	Ph:  732-745-6674
	Newark
	Newark Beth Israel Medical Center
		Clinical Trials Office - Newark Beth Israel Medical Center	Ph:  973-926-3136
	Paterson
	St. Joseph's Hospital and Medical Center
		Mary Bonilla	Ph:  973-754-3349
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
New York
	Albany
	Albany Medical Center Hospital
		Vikramjit Kanwar	Ph:  518-262-5513x25265
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	New Hyde Park
	Schneider Children's Hospital
		Arlene Redner	Ph:  718-470-3460
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	Ph:  212-305-8615
	NYU Cancer Institute at New York University Medical Center
		Elizabeth Raetz	Ph:  212-263-8400
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Barbara Asselin	Ph:  585-275-2981
	Syracuse
	SUNY Upstate Medical University Hospital
		Clinical Trials Office - SUNY Upstate Medical University Hospital	Ph:  315-464-5476
	Valhalla
	New York Medical College
		Fevzi Ozkaynak	Ph:  914-493-7997
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
	Presbyterian Cancer Center at Presbyterian Hospital
		Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital	Ph:  704-384-5369
	Durham
	Duke Comprehensive Cancer Center
		Clinical Trials Office - Duke Comprehensive Cancer Center	Ph:  888-275-3853
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
Ohio
	Cincinnati
	Cincinnati Children's Hospital Medical Center
		Clinical Trials Office - Cincinnati Children's Hospital Medical Center	Ph:  513-636-2799
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
	Rainbow Babies and Children's Hospital
		Yousif (Joe) Matloub	Ph:  216-844-3345
	Columbus
	Nationwide Children's Hospital
		Amanda Termuhlen	Ph:  614-722-3552
	Dayton
	Children's Medical Center - Dayton
		Emmett Broxson	Ph:  937-641-3111
	Toledo
	Medical University of Ohio Cancer Center
		Clinical Trials Office - Medical University of Ohio Cancer Center	Ph:  419-383-6583
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Rene McNall-Knapp	Ph:  405-271-5311
Oregon
	Portland
	Knight Cancer Institute at Oregon Health and Science University
		Clinical Trials Office - Knight Cancer Institute at Oregon Health and Science University	Ph:  503-494-1080
			Email: trials@ohsu.edu
	Legacy Emanuel Hospital and Health Center and Children's Hospital
		Clinical Trials Office - Legacy Emanuel Hospital and Health Center and Children's Hospital	Ph:  503-413-8199
Pennsylvania
	Bethlehem
	Lehigh Valley Hospital - Muhlenberg
		Philip Monteleone	Ph:  484-884-3333
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Clinical Trials Office - Geisinger Cancer Institute	Ph:  570-271-5251
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center	Ph:  717-531-3779
			Email: CTO@hmc.psu.edu
	Philadelphia
	Children's Hospital of Philadelphia
		Richard Aplenc	Ph:  267-426-7252
	St. Christopher's Hospital for Children
		Clinical Trials Office - St. Christopher's Hospital for Children	Ph:  215-427-8991
	Pittsburgh
	Children's Hospital of Pittsburgh
		Clinical Trials Office - Children's Hospital of Pittsburgh	Ph:  412-692-5573
South Carolina
	Columbia
	Palmetto Health South Carolina Cancer Center
		Clinical Trials Office - Palmetto Health South Carolina Cancer Center	Ph:  803-434-3680
	Greenville
	Greenville Hospital Cancer Center
		Clinical Trials Office - Greenville Hospital Cancer Center	Ph:  864-241-6251
South Dakota
	Sioux Falls
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Tennessee
	Chattanooga
	T.C. Thompson Children's Hospital
		Manoo Bhakta	Ph:  423-778-7289
	Knoxville
	East Tennessee Children's Hospital
		Ray Pais	Ph:  865-541-8266
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  800-811-8480
Texas
	Corpus Christi
	Driscoll Children's Hospital
		Clinical Trials Office - Driscoll Children's Hospital	Ph:  361-694-5311
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Ph:  866-460-4673; 214-648-7097
	Fort Worth
	Cook Children's Medical Center - Fort Worth
		Clinical Trials Office - Cook's Children's Medical Center	Ph:  682-885-2103
	Lubbock
	Covenant Children's Hospital
		Latha Prasannan	Ph:  806-725-4840
	San Antonio
	Methodist Children's Hospital of South Texas
		Michael Grimley	Ph:  210-575-7268
	University of Texas Health Science Center at San Antonio
		Paul Thomas	Ph:  210-704-2187
Utah
	Salt Lake City
	Primary Children's Medical Center
		Phillip Barnette	Ph:  801-662-4700
Vermont
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
Virginia
	Charlottesville
	University of Virginia Cancer Center
		Kimberly Dunsmore	Ph:  434-924-5105
	Portsmouth
	Naval Medical Center - Portsmouth
		Clinical Trials Office - Naval Medical Center - Portsmouth	Ph:  757-953-5939
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center	Ph:  804-628-1939
	Roanoke
	Carilion Medical Center for Children at Roanoke Community Hospital
		Mandy Atkinson	Ph:  540-981-7376
Washington
	Seattle
	Children's Hospital and Regional Medical Center - Seattle
		Julie Park	Ph:  206-987-2106
	Spokane
	Providence Cancer Center at Sacred Heart Medical Center
		Judy Felgenhauer	Ph:  509-474-2777
West Virginia
	Charleston
	West Virginia University Health Sciences Center - Charleston
		Allen Chauvenet	Ph:  304-388-1552
Wisconsin
	Green Bay
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Ph:  608-262-5223
	Marshfield
	Marshfield Clinic - Marshfield Center
		Clinical Trials Office - Marshfield Clinic - Marshfield Center	Ph:  800-782-1581 ext. 94457
	Milwaukee
	Midwest Children's Cancer Center at Children's Hospital of Wisconsin
		Michael Kelly	Ph:  414-456-4170
Australia
New South Wales
	Westmead
	Westmead Institute for Cancer Research at Westmead Hospital
		Geoffrey McCowage	Ph:  61298452122
Queensland
	Brisbane
	Royal Children's Hospital
		Helen Irving	Ph:  617-3636-8671
Western Australia
	Perth
	Princess Margaret Hospital for Children
		Catherine Cole	Ph:  011-6189340-8238
Canada
	Quebec
	Centre Hospitalier Universitaire de Quebec
		Bruno Michon	Ph:  418-656-4141X47191
Alberta
	Calgary
	Alberta Children's Hospital
		Douglas Strother	Ph:  403-955-7272
	Edmonton
	University of Alberta Hospital
		Sunil Jayantilal` Desai	Ph:  780-407-8829
British Columbia
	Vancouver
	Children's & Women's Hospital of British Columbia
		Mason Bond	Ph:  604-875-2322
Nova Scotia
	Halifax
	IWK Health Centre
		Margaret Yhap	Ph:  902-470-8778
Ontario
	Hamilton
	McMaster Children's Hospital at Hamilton Health Sciences
		Carol Portwine	Ph:  905-521-2100x73464
	Kingston
	Cancer Centre of Southeastern Ontario at Kingston General Hospital
		Mariana Silva	Ph:  613-5496666x3833
	London
	Children's Hospital of Western Ontario
		A. Cairney	Ph:  519-685-8494
	Ottawa
	Children's Hospital of Eastern Ontario
		Jacqueline Halton	Ph:  613-737-7600x2370
	Toronto
	Hospital for Sick Children
		Sylvain Baruchel	Ph:  416-813-7795
Quebec
	Montreal
		Yvan Samson	Ph:  514-345-4969
	Hopital Sainte Justine
		Yvan Samson	Ph:  418-656-4141x47191
New Zealand
	Auckland
	Starship Children's Health
		Lochie Teague	Ph:  64930749496368
Puerto Rico
	Santurce
	San Jorge Children's Hospital
		Luis Clavell	Ph:  787-728-1575

Registry Information
Official Title		Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma
Trial Start Date		2007-11-05
Trial Completion Date		2011-03-26 (estimated)
Registered in ClinicalTrials.gov		NCT00567567
Date Submitted to PDQ		2007-11-06
Information Last Verified		2009-11-06
NCI Grant/Contract Number		CA98543

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