Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

This randomized phase II trial is studying how well giving vinorelbine tartrate and cyclophosphamide together works in combination with bevacizumab or temsirolimus in treating patients with recurrent or refractory rhabdomyosarcoma. Drugs used in chemotherapy, such as vinorelbine tartrate and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of rhabdomyosarcoma by blocking blood flow to the tumor. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective when given together with bevacizumab or temsirolimus in treating rhabdomyosarcoma.

Further Study Information

PRIMARY OBJECTIVES:

l. To determine the feasibility of administering bevacizumab in combination with intravenous vinorelbine and cyclophosphamide (VC) in patients with recurrent rhabdomyosarcoma (RMS).

II. To determine the feasibility of administering temsirolimus in combination with VC in patients with recurrent RMS.

III. To estimate the event-free survival (EFS) of patients with recurrent/refractory RMS treated with bevacizumab and VC and compare with the EFS of those treated with temsirolimus and VC.

SECONDARY OBJECTIVES:

I. To estimate the initial (2 cycle) response rate of patients with recurrent/refractory RMS treated with bevacizumab and VC and compare with the response rate of those treated with temsirolimus and VC, and to also compare the best response rate on each regimen of protocol therapy.

II. To evaluate surrogate biological markers in patients with recurrent RMS and to estimate differences in these markers following treatment with bevacizumab and temsirolimus.

OUTLINE: This is a multicenter study. Patients are stratified according to histologic sub type at initial diagnosis. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive vinorelbine tartrate intravenously (IV) over 6-10 minutes on days 1 and 8 and cyclophosphamide IV over 30-60 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1.

ARM II: Patients receive vinorelbine tartrate and cyclophosphamide as in arm I. Patients also receive temsirolimus IV over 30-60 minutes on days 1, 8, and 15.

In both arms, treatment repeats every 21 days for 12 courses in the absence of disease progression or unacceptable toxicity. Blood and tissue samples may be collected for correlative studies.

After completion of study treatment, patients are followed up annually for 5 years.

Eligibility Criteria

Inclusion Criteria:

• Patients must have had a previous histological verification of rhabdomyosarcoma at original diagnosis

• Patients with first relapse or progression of rhabdomyosarcoma are eligible

• Patients with primary refractory disease are eligible

• Primary refractory disease is defined as first progression after receiving at least one course of cyclophosphamide or ifosfamide containing chemotherapy without prior demonstration of a radiographic response to chemotherapy (progression on irinotecan-containing chemotherapy without cyclophosphamide or ifosfamide containing chemotherapy will not be considered a first progression)

• Patients without measurable or evaluable disease are eligible

• Patients must have a Karnofsky or Lansky performance status score of >= 50%, corresponding to Eastern Cooperative Oncology Group (ECOG) categories of 0, 1, or 2

• Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

• Patients must have a life expectancy of >= 8 weeks

• Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

• No myelosuppressive chemotherapy within 3 weeks prior to entry onto this study (4 weeks if prior nitrosourea)

• Patients may have received prior therapy with oral tyrosine kinase inhibitors or other similar agents

• At least 7 days must have elapsed since the completion of therapy with a biologic agent and all toxicities must have resolved to < grade 2 prior to enrollment

• 3 half-lives (or 6 weeks) must have elapsed since previous monoclonal antibody therapy prior to enrollment on this study

• No myeloid growth factor within 1 week prior to entry onto this study

• At least 4 weeks must have elapsed between radiotherapy and study entry

• Previously radiated lesions cannot be used to assess response unless those sites are the sites of disease progression

• For autologous stem cell transplantation (SCT), >= 3 months must have elapsed

• For allogeneic SCT, >= 6 months must have elapsed and no evidence of active graft vs host disease

• Patients must have recovered from any surgical procedure before enrolling on this study

• Minor surgical procedures (e.g., biopsies involving core or fine-needle aspiration procedures, infusaport or Broviac line placement, paracentesis, or thoracocentesis) need to have fully healed and occurred > 7 days prior to enrollment

• Patients who have had a major surgical procedure (such as laparotomy, thoracotomy, open biopsy, or resection of tumor) can only be enrolled on study > 28 days from such procedure

• Peripheral absolute neutrophil count (ANC) >= 750/μL

• Platelet count >= 75,000/μL (transfusion independent, defined as without transfusion for >= 1 week prior to enrollment)

• Hemoglobin >= 8.0 g/dL (may receive packed red blood cells [PRBC] transfusions)

• Bone marrow disease involvement of tumor is allowed, however, peripheral blood count criteria must still be met

• 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:

• =< 0.4 mg/dL (for patients aged 1 month to < 6 months)

• =< 0.5 mg/dL (for patients aged 6 months to < 1 year)

• =< 0.6 mg/dL (for patients aged 1 to < 2 years)

• =< 0.8 mg/dL (for patients aged 2 to < 6 years)

• =< 1 mg/dL (for patients aged 6 to < 10 years)

• =< 1.2 mg/dL (for patients aged 10 to < 13 years)

• =< 1.4 mg/dL (for female patients aged >= 13 years)

• =< 1.5 mg/dL (for male patients aged 13 to < 16 years)

• =< 1.7 mg/dL (for male patients aged >= 16 years)

• Urine protein level:

• For patients aged =< 17 years, UPC ratio must be =< 1 for patient to be eligible

• For patients aged > 17 years, urine protein should be screened by urine analysis; if protein is 2+ or higher, 24-hour urine protein must be obtained and the level must be < 1,000 mg for patient enrollment

• Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

• Shortening fraction of >= 27% by echocardiogram or ejection fraction of >= 50% by radionuclide angiogram

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

Exclusion Criteria:

• Patients with botryoid histology, any stage or group, are ineligible

• Patients with embryonal histology, stage I or clinical group 1 at initial disease presentation, who present with local or regional recurrence, are ineligible

• Patients who previously received craniospinal irradiation are ineligible

• Patients who previously received vinorelbine, bevacizumab, temsirolimus, or any other direct VEGF/VEGFR- or mTOR- targeting agents are ineligible

• Patients with known central nervous system (CNS) disease (excluding intracranial/intraspinal extension secondary to local progression of a parameningeal or paraspinal primary), except for those with treated brain metastasis, are ineligible

• Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 3 months, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT])

• Stable dose of anticonvulsants are allowed

• Treatment for brain metastases may include whole-brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent), or a combination as deemed appropriate by the treating physician

• Patients with CNS metastases treated within 3 months prior to enrollment by neurosurgical resection or brain biopsy are ineligible

• Patients who receive radiation or chemotherapy (inclusive of palliative intent) for first disease progression or relapse of rhabdomyosarcoma prior to enrollment are ineligible

• Pregnant or nursing

• Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained

• Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation

• Patients with a documented chronic non-healing wound, ulcer, or significant trauma injury (those with bone fractures, including pathological fractures, or requiring surgical intervention) within 28 days prior to beginning therapy are ineligible

• Patients with evidence of intratumoral hemorrhage, gastrointestinal bleeding, or on anticoagulation for thrombosis or history of thrombosis are ineligible

• Patients with uncontrolled hypertension are ineligible; uncontrolled hypertension is defined as follows:

• Patients aged =< 17 years: greater than 95th percentile systolic and diastolic blood pressure based on age and height that is not controlled by one antihypertensive medication

• Patients aged > 17 years: systolic blood pressure >= 160 mm Hg and/or diastolic blood pressure >= 90 mm Hg that is not controlled by one antihypertensive medication

• Patients currently taking anticoagulants or antiplatelet agents with the exception of aspirin (=< 81 mg/day) are ineligible

• Patients with history of central venous catheter (CVC)-associated thrombosis requiring systemic anticoagulation are ineligible

• NOTE: Patients with history of sluggish flow from CVC or CVC-associated thrombosis treated with tissue plasminogen activator (TPA) only are not excluded

• Patients with clinically significant cardiovascular disease are excluded:

• History of cerebrovascular accident (CVA) within the prior 6 months

• Myocardial infarction or unstable angina within the prior 6 months

• New York Heart Association grade 2 or greater congestive heart failure

• Serious and inadequately controlled cardiac arrhythmia

• Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection)

• Clinically significant peripheral vascular disease

• Patients diagnosed with rhabdomyosarcoma as a second malignant neoplasm are not eligible

• Patients with history of any second malignant neoplasm who have received chemotherapy or radiation for the treatment of that malignancy are not eligible

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Leo Mascarenhas

Principal Investigator

Peter Adamson		Ph: 612-624-8651
		Email: Adamson@email.chop.edu

U.S.A.
Alabama
	Birmingham
	Children's Hospital of Alabama at University of Alabama at Birmingham
		Alyssa T Reddy	Ph: 205-934-0309
	UAB Comprehensive Cancer Center
		Alyssa T Reddy	Ph: 205-934-0309
Arkansas
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		David L Becton	Ph: 501-364-7373
California
	Downey
	Southern California Permanente Medical Group
		Robert M Cooper	Ph: 626-564-3455
	Duarte
	City of Hope Comprehensive Cancer Center
		Anna B Pawlowska	Ph: 800-826-4673
			Email: becomingapatient@coh.org
	Loma Linda
	Loma Linda University Cancer Institute at Loma Linda University Medical Center
		Antranik A Bedros	Ph: 909-558-3375
	Long Beach
	Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
		Jerry Z Finklestein	Ph: 562-933-5437
	Los Angeles
	Childrens Hospital Los Angeles
		Leo Mascarenhas	Ph: 323-361-4110
	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
		Sara A Hurvitz	Ph: 888-798-0719
	Madera
	Children's Hospital Central California
		Vonda L Crouse	Ph: 866-353-5437
	Oakland
	Children's Hospital and Research Center Oakland
		Carla B Golden	Ph: 510-450-7600
	Orange
	Children's Hospital of Orange County
		Violet Shen	Ph: 714-997-3000
	Palo Alto
	Lucile Packard Children's Hospital at Stanford University Medical Center
		Neyssa M Marina	Ph: 650-498-7061
			Email: clinicaltrials@med.stanford.edu
	Sacramento
	University of California Davis Cancer Center
		Jay Michael S Balagtas	Ph: 916-734-3089
	San Diego
	Rady Children's Hospital - San Diego
		William D Roberts	Ph: 858-966-5934
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Robert E Goldsby	Ph: 877-827-3222
Colorado
	Aurora
	Children's Hospital Colorado Center for Cancer and Blood Disorders
		Kelly W Maloney	Ph: 720-777-6672
	Denver
	Presbyterian - St. Luke's Medical Center
		Jennifer J Clark	Ph: 866-775-6246
Connecticut
	Hartford
	Connecticut Children's Medical Center
		Michael S Isakoff	Ph: 860-545-9981
	New Haven
	Yale Cancer Center
		Nina S Kadan-Lottick	Ph: 203-785-5702
Delaware
	Wilmington
	Alfred I. duPont Hospital for Children
		Christopher N Frantz	Ph: 302-651-5755
District of Columbia
	Washington
	Children's National Medical Center
		Jeffrey S Dome	Ph: 202-884-2549
Florida
	Fort Myers
	Lee Cancer Care of Lee Memorial Health System
		Emad K Salman	Ph: 239-343-5333
	Hollywood
	Joe DiMaggio Children's Hospital
		Iftikhar Hanif	Ph: 954-265-2234
	Jacksonville
	Nemours Children's Clinic
		Eric S Sandler	Ph: 904-697-3529
	Miami
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		Julio C Barredo	Ph: 866-574-5124
			Email: Sylvester@emergingmed.com
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clifford A Selsky	Ph: 407-303-5623
	M.D. Anderson Cancer Center at Orlando
		Vincent F Giusti	Ph: 321-841-7246
	Nemours Children's Clinic - Orlando
		Ramamoorthy Nagasubramanian	Ph: 407-650-7150
	Pensacola
	Nemours Children's Clinic - Pensacola
		Jeffrey H Schwartz	Ph: 904-697-3529
	Saint Petersburg
	All Children's Hospital
		Gregory A Hale	Ph: 727-767-2423
			Email: HamblinF@allkids.org
	Tampa
	St. Joseph's Children's Hospital of Tampa
		Hardeo K Panchoosingh	Ph: 800-882-4123
	West Palm Beach
	Kaplan Cancer Center at St. Mary's Medical Center
		Narayana Gowda	Ph: 888-823-5923
			Email: ctsucontact@westat.com
Georgia
	Atlanta
	AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
		Howard M Katzenstein	Ph: 888-785-1112
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		J. Martin Johnston	Ph: 912-350-8568
Hawaii
	Honolulu
	Cancer Research Center of Hawaii
		Robert W Wilkinson	Ph: 808-983-6090
Idaho
	Boise
	Mountain States Tumor Institute at St. Luke's Regional Medical Center
		Eugenia Chang	Ph: 800-845-4624
Illinois
	Chicago
	Ann and Robert H. Lurie Children's Hospital of Chicago
		David O Walterhouse	Ph: 773-880-4562
	University of Chicago Cancer Research Center
		Susan L Cohn	Ph: 773-834-7424
	University of Illinois Cancer Center
		Mary L Schmidt	Ph: 312-355-3046
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Ricarchito B Manera	Ph: 708-226-4357
	Peoria
	Saint Jude Midwest Affiliate
		Pedro A De Alarcon	Ph: 309-655-3258
	Springfield
	Simmons Cooper Cancer Institute
		Gregory P Brandt	Ph: 217-545-7929
Indiana
	Indianapolis
	Riley's Children Cancer Center at Riley Hospital for Children
		Robert J Fallon	Ph: 317-274-2552
	St. Vincent Indianapolis Hospital
		Bassem I Razzouk	Ph: 317-338-2194
Iowa
	Des Moines
	Blank Children's Hospital
		Wendy L Woods-Swafford	Ph: 888-823-5923
			Email: ctsucontact@westat.com
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Raymond Tannous	Ph: 800-237-1225
Kentucky
	Lexington
	University of Kentucky Chandler Medical Center
		Martha F Greenwood	Ph: 859-257-3379
	Louisville
	Kosair Children's Hospital
		Salvatore J Bertolone	Ph: 866-530-5516
Louisiana
	New Orleans
	Ochsner Cancer Institute at Ochsner Clinic Foundation
		Rajasekharan P. Warrier	Ph: 504-894-5377
	Tulane Cancer Center at Tulane University Hospital and Clinic
		Tammuella C Singleton	Ph: 504-988-6121
Maine
	Bangor
	CancerCare of Maine at Eastern Maine Medical Center
		Sarah J Fryberger	Ph: 207-973-4274
	Scarborough
	Maine Children's Cancer Program at Barbara Bush Children's Hospital
		Eric C Larsen	Ph: 207-396-8090
			Email: wrighd@mmc.org
Maryland
	Baltimore
	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
		Joseph M Wiley	Ph: 410-601-6120
			Email: pridgely@lifebridgehealth.org
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		David M Loeb	Ph: 410-955-8804
			Email: jhcccro@jhmi.edu
	Bethesda
	National Naval Medical Center
		Anne B Warwick	Ph: 301-319-2100
Massachusetts
	Boston
	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
		Carlos Rodriguez-Galindo	Ph: 866-790-4500
	Floating Hospital for Children at Tufts - New England Medical Center
		Johannes E Wolff	Ph: 617-636-5000
			Email: ContactUsCancerCenter@TuftsMedicalCenter.org
	Massachusetts General Hospital
		Howard J Weinstein	Ph: 877-726-5130
Michigan
	Detroit
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Hadi Sawaf	Ph: 313-343-3166
	Wayne State University
		Maxim Y Yankelevich	Ph: 313-576-9363
	Grand Rapids
	Helen DeVos Children's Hospital at Spectrum Health
		David S Dickens	Ph: 616-267-1925
	Kalamazoo
	Bronson Methodist Hospital
		Jeffrey S Lobel	Ph: 800-227-2345
	Western Michigan University School of Medicine Clinics
		Jeffrey S Lobel	Ph: 800-227-2345
	Lansing
	Breslin Cancer Center at Ingham Regional Medical Center
		Renuka Gera	Ph: 517-334-2765
Minnesota
	Minneapolis
	Children's Hospitals and Clinics of Minnesota - Minneapolis
		Bruce C Bostrom	Ph: 612-813-5193
	Masonic Cancer Center at University of Minnesota
		Brenda J Weigel	Ph: 612-624-2620
	Rochester
	Mayo Clinic Cancer Center
		Carola A. S. Arndt	Ph: 507-538-7623
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Gail C Megason	Ph: 601-815-6700
Missouri
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Thomas W Loew	Ph: 573-882-7440
	Kansas City
	Children's Mercy Hospital
		Kathleen A Neville	Ph: 816-234-3265
	Saint Louis
	Cardinal Glennon Children's Hospital
		William S Ferguson	Ph: 314-268-4000
	David C. Pratt Cancer Center at St. John's Mercy
		Bethany G. Sleckman	Ph: 913-948-5588
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Robert J Hayashi	Ph: 800-600-3606
			Email: info@siteman.wustl.edu
Nebraska
	Omaha
	Children's Hospital
		Minnie Abromowitch	Ph: 402-955-3949
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Peter F Coccia	Ph: 800-999-5465
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		Jonathan Bernstein	Ph: 702-384-0013
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Sara Chaffee	Ph: 800-639-6918
			Email: cancer.research.nurse@dartmouth.edu
New Jersey
	Hackensack
	Hackensack University Medical Center Cancer Center
		Burton E Appel	Ph: 201-996-2879
	Livingston
	St. Barnabas Medical Center Cancer Center
		Stacey Rifkin-Zenenberg	Ph: 973-926-7230
	Morristown
	Carol G. Simon Cancer Center at Morristown Memorial Hospital
		Steven L Halpern	Ph: 973-971-5900
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Richard A Drachtman	Ph: 732-235-8675
	Saint Peter's University Hospital
		Stanley Calderwood	Ph: 732-745-8600ext6163
			Email: kcovert@saintpetersuh.com
	Newark
	Newark Beth Israel Medical Center
		Peri Kamalakar	Ph: 973-926-7230
	Paterson
	St. Joseph's Hospital and Medical Center
		Mary A Bonilla	Ph: 973-754-2909
	Summit
	Overlook Hospital
		Steven L Halpern	Ph: 973-971-5900
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Koh B Boayue	Ph: 505-272-6972
New York
	Albany
	Albany Medical Center Hospital
		Vikramjit S Kanwar	Ph: 518-262-3368
	Bronx
	Montefiore Medical Center
		Rosanna J Ricafort	Ph: 718-904-2730
			Email: aecc@aecom.yu.edu
	Buffalo
	Roswell Park Cancer Institute
		Martin L Brecher	Ph: 877-275-7724
	Mineola
	Winthrop University Hospital
		Mark E Weinblatt	Ph: 866-946-8476
	New Hyde Park
	Schneider Children's Hospital
		Carolyn F Levy	Ph: 718-470-3470
	New York
	Memorial Sloan-Kettering Cancer Center
		Peter G Steinherz	Ph: 212-639-7202
	New York University Medical Center
		Elizabeth A Raetz	Ph: 212-263-4434
			Email: prmc.coordinator@nyumc.org
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Lisa R Hackney	Ph: 585-275-5830
	Stony Brook
	Stony Brook University Cancer Center
		Robert I Parker	Ph: 800-862-2215
	Syracuse
	SUNY Upstate Medical University Hospital
		Karol H Kerr	Ph: 315-464-5476
North Carolina
	Asheville
	Mission Hospitals - Memorial Campus
		Orren Beaty	Ph: 828-213-4150
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Stuart H Gold	Ph: 877-668-0683
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Joel A Kaplan	Ph: 704-355-2884
	Presbyterian Cancer Center at Presbyterian Hospital
		Paulette C Bryant	Ph: 704-384-5369
	Durham
	Duke Cancer Institute
		Susan G Kreissman	Ph: 888-275-3853
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Thomas W McLean	Ph: 336-713-6771
North Dakota
	Fargo
	Roger Maris Cancer Center at MeritCare Hospital
		Nathan L Kobrinsky	Ph: 701-234-6161
Ohio
	Akron
	Akron Children's Hospital
		Steven J Kuerbitz	Ph: 330-543-3193
	Cincinnati
	Cincinnati Children's Hospital Medical Center
		John P Perentesis	Ph: 513-636-2799
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Margaret C Thompson	Ph: 866-223-8100
	Seidman Cancer Center at University Hospitals/Case Medical Center
		Yousif (Joe) H Matloub	Ph: 216-844-5437
	Columbus
	Nationwide Children's Hospital
		Mark A Ranalli	Ph: 614-722-2708
	Dayton
	Dayton Children's - Dayton
		Emmett H Broxson	Ph: 800-228-4055
	Toledo
	Mercy Children's Hospital
		Rama Jasty	Ph: 419-251-8210
	Toledo Hospital
		Dagmar T Stein	Ph: 419-824-1842
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Rene Y McNall-Knapp	Ph: 405-271-4272
			Email: julie-traylor@ouhsc.edu
	Tulsa
	Natalie Warren Bryant Cancer Center at St. Francis Hospital
		Gregory B Kirkpatrick	Ph: 918-494-2200
Oregon
	Portland
	Knight Cancer Institute at Oregon Health and Science University
		Linda C. Stork	Ph: 503-494-1080
			Email: trials@ohsu.edu
	Legacy Emanuel Children's Hospital
		Janice F Olson	Ph: 503-413-2560
	Legacy Emanuel Hospital and Health Center and Children's Hospital
		Janice F Olson	Ph: 503-413-2560
Pennsylvania
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Jeffrey S Taylor	Ph: 570-271-5251
	Hershey
	Penn State Children's Hospital
		Lisa M McGregor	Ph: 717-531-6012
	Philadelphia
	Children's Hospital of Philadelphia
		Frank M Balis	Ph: 215-590-2810
	Pittsburgh
	Children's Hospital of Pittsburgh of UPMC
		Scott H Maurer	Ph: 412-692-5573
Rhode Island
	Providence
	Rhode Island Hospital Comprehensive Cancer Center
		Cindy L Schwartz	Ph: 401-444-1488
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Jacqueline M Kraveka	Ph: 843-792-9321
	Columbia
	Palmetto Health South Carolina Cancer Center
		Ronnie W. Neuberg	Ph: 803-434-3680
	Greenville
	BI-LO Charities Children's Cancer Center
		Cary E Stroud	Ph: 864-241-6251
	Cancer Centers of the Carolinas - Faris Road
		Cary E Stroud	Ph: 864-241-6251
South Dakota
	Sioux Falls
	Sanford Cancer Center at Sanford USD Medical Center
		Kayelyn J Wagner	Ph: 605-328-1367
Tennessee
	Chattanooga
	T.C. Thompson Children's Hospital
		Manoo G Bhakta	Ph: 423-778-7289
	Knoxville
	East Tennessee Children's Hospital
		Ray C Pais	Ph: 865-541-8266
	Memphis
	St. Jude Children's Research Hospital
		Alberto S Pappo	Ph: 901-595-4644
			Email: burton@bcm.edu
	Nashville
	Vanderbilt-Ingram Cancer Center
		Scott C Borinstein	Ph: 800-811-8480
Texas
	Amarillo
	Texas Tech University Health Sciences Center School of Medicine - Amarillo
		Osvaldo Regueira	Ph: 806-354-5411
	Austin
	Dell Children's Medical Center of Central Texas
		Sharon K Lockhart	Ph: 512-324-8022
	Corpus Christi
	Driscoll Children's Hospital
		M. C Johnson	Ph: 361-694-5311
	Dallas
	Medical City Dallas Hospital
		Carl Lenarsky	Ph: 972-566-5588
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Naomi J Winick	Ph: 214-648-7097
	Fort Sam Houston
	Brooke Army Medical Center
		Della L Howell	Ph: 210-292-7311
	Fort Worth
	Cook Children's Medical Center - Fort Worth
		Mary Meaghan P Granger	Ph: 682-885-2103
	Houston
	Dan L. Duncan Cancer Center at Baylor College of Medicine
		Jodi Muscal	Ph: 713-798-1354
			Email: burton@bcm.edu
	M. D. Anderson Cancer Center at University of Texas
		Winston W Huh	Ph: 713-792-3245
			Email: whuh@mdanderson.org
	Univeristy of Texas M.D. Anderson Cancer Center
		Winston W Huh	Ph: 713-792-3245
	Lubbock
	Covenant Children's Hospital
		Latha Prasannan	Ph: 806-725-8000
			Email: jaccresearch@covhs.org
	San Antonio
	University of Texas Health Science Center at San Antonio
		Anne-Marie R Langevin	Ph: 210-567-0653
			Email: che@uthscsa.edu
	Temple
	Scott and White Cancer Institute
		Guy H Grayson	Ph: 254-724-5407
Utah
	Salt Lake City
	Primary Children's Medical Center
		Phillip E Barnette	Ph: 801-585-5270
Vermont
	Burlington
	Vermont Cancer Center at University of Vermont
		Alan C Homans	Ph: 802-656-8990
Virginia
	Charlottesville
	University of Virginia Cancer Center
		Kimberly P Dunsmore	Ph: 434-243-6143
	Falls Church
	Inova Fairfax Hospital
		Marshall A Schorin	Ph: 703-208-6650
	Norfolk
	Children's Hospital of The King's Daughters
		Eric J Lowe	Ph: 757-668-7243
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Kamar Godder	Ph: 804-628-1939
Washington
	Seattle
	Children's Hospital and Regional Medical Center - Seattle
		Douglas S Hawkins	Ph: 866-987-2000
	Spokane
	Providence Cancer Center at Sacred Heart Medical Center
		Judy L Felgenhauer	Ph: 800-228-6618
			Email: HopeBeginsHere@providence.org
	Tacoma
	Mary Bridge Children's Hospital and Health Center - Tacoma
		Ronald R Louie	Ph: 800-552-1419
West Virginia
	Charleston
	West Virginia University Medical School - Charleston
		Allen R Chauvenet	Ph: 304-388-9944
Wisconsin
	Green Bay
	St. Vincent Hospital Regional Cancer Center
		John R Hill	Ph: 920-433-8889
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Kenneth B De Santes	Ph: 608-262-5223
	Milwaukee
	Midwest Children's Cancer Center at Children's Hospital of Wisconsin
		Michael E Kelly	Ph: 414-805-4380
Australia
New South Wales
	Randwick
	Sydney Children's Hospital
		Draga Barbaric	Ph: (02) 9382-1721
	Sydney
	Children's Hospital at Westmead
		Geoffrey B McCowage	Ph: 61-2-9845 1400
Western Australia
	Perth
	Princess Margaret Hospital for Children
		Catherine H Cole	Ph: (08) 9340 8330
			Email: admin@childcancerresearch.com.au
Canada
Alberta
	Calgary
	Alberta Children's Hospital
		Douglas R Strother	Ph: 403-220-6898
			Email: research4kids@ucalgary.ca
	Edmonton
	University of Alberta Hospital
		Sunil Jayantilal` S Desai	Ph: 780-407-6615
			Email: val.taylor@albertahealthservices.ca
British Columbia
	Vancouver
	Children's and Women's Hospital of British Columbia
		Caron Strahlendorf	Ph: 604-875-2345ext6477
Manitoba
	Winnipeg
	CancerCare Manitoba
		Rochelle A Yanofsky	Ph: 866-561-1026
			Email: CIO_Web@cancercare.mb.ca
Newfoundland and Labrador
	Saint John's
	Janeway Children's Health and Rehabilitation Centre
		Lisa Anne B Goodyear	Ph: 866-722-1126
Nova Scotia
	Halifax
	IWK Health Centre
		Margaret C Yhap	Ph: 902-470-8394
Ontario
	Hamilton
	McMaster Children's Hospital at Hamilton Health Sciences
		Carol Portwine	Ph: 905-521-2100ext74595
		Carol Portwine	Ph: 905-521-2100ext74595
	Kingston
	Cancer Centre of Southeastern Ontario at Kingston General Hospital
		Mariana P Silva	Ph: 613-544-2630
	London
	Children's Hospital of Western Ontario
		Anne E Cairney	Ph: 519-685-8306
	Toronto
	Hospital for Sick Children
		Paul C Nathan	Ph: 416-813-7654ext2027
			Email: jason.mcguire@sickkids.ca
Quebec
	Montreal
	Hopital Sainte Justine
		Yvan Samson	Ph: 514-345-4931
	Montreal Children's Hospital at McGill University Health Center
		Sharon B Abish	Ph: 514-412-4445
			Email: info@thechildren.com
	Ste-Foy
	Centre de Recherche du Centre Hospitalier de l'Universite Laval
		Bruno Michon	Ph: 418-525-4444
Saskatchewan
	Regina
	Allan Blair Cancer Centre at Pasqua Hospital
		Mansoor M Haq	Ph: 306-766-2213
	Saskatoon
	Saskatoon Cancer Centre at the University of Saskatchewan
		Christopher Mpofu	Ph: 306-655-2914
New Zealand
	Christchurch
	Christchurch Hospital
		Lochie R Teague	Ph:  0800 728 436
Auckland
	Grafton
	Starship Children's Health
		Lochie R Teague	Ph:  0800 728 436

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01222715
Information obtained from ClinicalTrials.gov on April 16, 2013