Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma
Conditions
Adult Supratentorial Primitive Neuroectodermal Tumor (PNET) - Childhood Supratentorial Primitive Neuroectodermal Tumor - Ewing Sarcoma of Bone - Extraosseous Ewing Sarcoma - Extraosseous Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor - Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor - Peripheral Primitive Neuroectodermal Tumor of the Kidney - Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor
Conditions: official terms
Kidney Neoplasms - Neuroectodermal Tumors - Neuroectodermal Tumors, Primitive - Neuroectodermal Tumors, Primitive, Peripheral - Sarcoma - Sarcoma, Ewing
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: vincristine sulfate Type: Drug
Name: doxorubicin hydrochloride Type: Drug
Name: cyclophosphamide Type: Drug
Name: ifosfamide Type: Drug
Name: etoposide Type: Drug
Name: topotecan hydrochloride Type: Drug
Name: laboratory biomarker analysis Type: Other
Overall Status
Recruiting
Summary
This randomized phase III trial studies combination chemotherapy to see how well it works compared to combination chemotherapy with topotecan hydrochloride in treating patients with non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with topotecan hydrochloride in treating Ewing sarcoma.
Detailed Description
PRIMARY OBJECTIVES:

l. Test the effect of the combination of vincristine (vincristine sulfate), cyclophosphamide, and topotecan (topotecan hydrochloride) (VTC) added to the standard 5-drug chemotherapy interval-compressed backbone on event-free and overall survival of children and young adults with Ewing sarcoma.

SECONDARY OBJECTIVES:

I. To evaluate initial volumetric tumor size as a prognostic factor for event free survival (EFS) in patients with localized Ewing tumors.

II. To evaluate histologic response as a prognostic factor for EFS in patients with localized Ewing tumors.

III. To continue evaluation of biologic markers both as related to prognosis and as eventual therapeutic targets via encouraging concurrent enrollment on a Ewing sarcoma specimen-collection study.

IV. To evaluate imaging response by fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) as a prognostic factor for EFS.

V. To evaluate the effects of the type of local therapy on EFS and overall survival.

VI. To evaluate the effect of local surgical margins in conjunction with histologic response on EFS in patients with localized Ewing tumors.

VII. To evaluate the effect of local therapy modality (surgery, radiotherapy, or a combination) as well as the type of surgical reconstruction on musculoskeletal complications.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I:

INDUCTION THERAPY: Patients receive vincristine sulfate intravenously (IV) on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11.

CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19.

ARM II:

INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1 and 9, and on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm I; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11.

CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19.

Patients with responsive or stable disease undergo may undergo surgery alone in week 13 if lesion can be complete resected with negative margins and with reasonable functional result. Patients with unresectable lesions or inadequate margins after surgery receive radiotherapy during weeks 1-7. Patients with bulky lesions in surgically difficult sites such as the spine, skull, and periacetabular pelvis, patients with a poor response to induction chemotherapy, or those patients in whom surgery would result in unacceptable functional results may undergo radiotherapy alone in weeks 1-7 of consolidation therapy, and surgery should be performed after completion of consolidation chemotherapy. Patients with microscopic residual disease after planned pre-operative radiotherapy receive additional radiotherapy.

After completion of study therapy, patients are followed up every 3 months for 3 years and then every 6 months for 2 years.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 50 Years
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

- Patients with newly diagnosed, biopsy confirmed, extracranial, non-metastatic Ewing sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue are eligible for this study; note:

- For the purpose of this study, chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology or ipsilateral pleural based secondary tumor nodules will be considered localized disease

- Patients with regional node involvement, based on clinical suspicion confirmed by pathologic documentation are considered to be non-metastatic

- Patients with discontinuous osseous lesions within the same bone are considered to be non-metastatic

- Tumors arising in the bony skull (extra-dural) are considered to be extracranial

- Patient eligibility will be based on a diagnosis of Ewing sarcoma or PNET by institutional pathologist

- No prior chemotherapy or radiation therapy is allowed; patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection; patients will still be eligible if unplanned excision was attempted or accomplished as long as adequate imaging was obtained prior to surgery

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70mL/min/1.73 m^2 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

- 13 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 x upper limit of normal (ULN) for age

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age

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

Exclusion Criteria:

- Patients must have no evidence of metastatic disease; metastatic disease:

- Are lesions which are discontinuous from the primary tumor, are not regional lymph nodes and do not share a body cavity with the primary tumor; if there is any doubt whether lesions are metastatic, a biopsy of those lesions should be taken

- Skeletal lesions in adjacent bones (trans-articular)

- Contralateral pleural effusion and contralateral pleural nodules

- Distant lymph node involvement

- Patients with pulmonary nodules are considered to have metastatic disease if the patient has:

- Solitary nodule > 0.5 cm or multiple nodules of > 0.3 cm unless biopsied and negative for Ewing's

- Biopsies of solitary nodule =< 0.5 cm or multiple nodules =< 0.3 cm are not required but if performed and positive indicate metastatic disease

- Patients whose tumors arise in the dural and intra-dural soft tissues of the cranium and spine are not eligible

- Patients with pathologic diagnoses other than Ewing sarcoma will be excluded

- Patients diagnosed with Ewing Sarcoma as a second malignant neoplasm are not eligible if they have received chemotherapy or radiation for the treatment of their primary malignancy

- Pregnant women will not be entered on this study; pregnancy tests must be obtained in female patients who are post-menarchal; lactating females may not participate unless they have agreed not to breastfeed their infants; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study treatment

- 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
Locations
Children's Hospital of Alabama
Birmingham, Alabama, United States
Status: Recruiting
Contact: Alyssa T. Reddy - 205-934-0309
University of Alabama at Birmingham
Birmingham, Alabama, United States
Status: Recruiting
Contact: Alyssa T. Reddy - 205-934-0309
University of South Alabama
Mobile, Alabama, United States
Status: Terminated
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Status: Recruiting
Contact: Jessica Boklan - 602-546-0920
University of Arizona Health Sciences Center
Tucson, Arizona, United States
Status: Recruiting
Contact: Brenda J. Wittman - 520-626-9008
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Status: Recruiting
Contact: David L. Becton - 501-364-7373
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Status: Withdrawn
Southern California Permanente Medical Group
Downey, California, United States
Status: Recruiting
Contact: Robert M. Cooper - 626-564-3455
City of Hope
Duarte, California, United States
Status: Recruiting
Contact: Anna B. Pawlowska - 800-826-4673 - becomingapatient@coh.org
Loma Linda University Medical Center
Loma Linda, California, United States
Status: Recruiting
Contact: Antranik A. Bedros - 909-558-3375
Miller Children's Hospital
Long Beach, California, United States
Status: Recruiting
Contact: Amanda M. Termuhlen - 562-933-5437
Cedars-Sinai Medical Center
Los Angeles, California, United States
Status: Recruiting
Contact: Fataneh (Fae) Majlessipour - 310-423-8965
Children's Hospital Los Angeles
Los Angeles, California, United States
Status: Recruiting
Contact: Leo Mascarenhas - 323-361-4110
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Status: Recruiting
Contact: Pamela H. Kempert - 310-825-6708
Mattel Children's Hospital UCLA
Los Angeles, California, United States
Status: Recruiting
Contact: Pamela H. Kempert - 310-825-6708
Children's Hospital Central California
Madera, California, United States
Status: Recruiting
Contact: Vonda L. Crouse - 866-353-5437
Children's Hospital and Research Center at Oakland
Oakland, California, United States
Status: Recruiting
Contact: Carla B. Golden - 510-450-7600
Kaiser Permanente-Oakland
Oakland, California, United States
Status: Recruiting
Contact: Steven K. Bergstrom - 626-564-3455
Childrens Hospital of Orange County
Orange, California, United States
Status: Recruiting
Contact: Violet Shen - 714-997-3000
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States
Status: Recruiting
Contact: Leonard S. Sender - 877-827-8839 - ucstudy@uci.edu
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
Status: Recruiting
Contact: Neyssa M. Marina - 650-498-7061 - clinicaltrials@med.stanford.edu
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Status: Recruiting
Contact: Jay Michael S. Balagtas - 916-734-3089
Rady Children's Hospital - San Diego
San Diego, California, United States
Status: Recruiting
Contact: William D. Roberts - 858-966-5934
University of California San Francisco Medical Center-Parnassus
San Francisco, California, United States
Status: Recruiting
Contact: Steven G. DuBois - 877-827-3222
Children's Hospital Colorado
Aurora, Colorado, United States
Status: Recruiting
Contact: Timothy P. Garrington - 720-777-6672
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States
Status: Recruiting
Contact: Jennifer J. Clark - 866-775-6246
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Status: Recruiting
Contact: Michael S. Isakoff - 860-545-9981
Yale University
New Haven, Connecticut, United States
Status: Recruiting
Contact: Nina S. Kadan-Lottick - 203-785-5702
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States
Status: Recruiting
Contact: Christopher N. Frantz - 302-651-5755
Children's National Medical Center
Washington, District of Columbia, United States
Status: Recruiting
Contact: Jeffrey S. Dome - 202-884-2549
Lombardi Comprehensive Cancer Center at Georgetown University
Washington, District of Columbia, United States
Status: Recruiting
Contact: Aziza T. Shad - 202-444-0381
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Status: Recruiting
Contact: Hector M. Rodriguez-Cortes - 954-355-5346
Lee Memorial Health System
Fort Myers, Florida, United States
Status: Withdrawn
The Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
Status: Recruiting
Contact: Emad K. Salman - 239-343-5333
University of Florida
Gainesville, Florida, United States
Status: Recruiting
Contact: Amy A. Smith - 352-273-8675
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Status: Recruiting
Contact: Iftikhar Hanif - 954-265-2234
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, United States
Status: Recruiting
Contact: Scott M. Bradfield - 904-697-3529
Baptist Hospital of Miami
Miami, Florida, United States
Status: Recruiting
Contact: Doured Daghistani - 800-599-2456 - cancerinfo@baptisthealth.net
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Status: Recruiting
Contact: Julio C. Barredo - 866-574-5124 - Sylvester@emergingmed.com
Florida Hospital
Orlando, Florida, United States
Status: Recruiting
Contact: Fouad M. Hajjar - 407-303-5623
M D Anderson Cancer Center- Orlando
Orlando, Florida, United States
Status: Recruiting
Contact: Vincent F. Giusti - 321-841-7246
Nemours Children's Hospital
Orlando, Florida, United States
Status: Recruiting
Contact: Ramamoorthy Nagasubramanian - 407-650-7150
Nemours Childrens Clinic - Orlando
Orlando, Florida, United States
Status: Withdrawn
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
Status: Recruiting
Contact: Jeffrey H. Schwartz - 904-697-3529
All Children's Hospital
Saint Petersburg, Florida, United States
Status: Recruiting
Contact: Gregory A. Hale - 727-767-2423 - HamblinF@allkids.org
Saint Joseph Children's Hospital of Tampa
Tampa, Florida, United States
Status: Recruiting
Contact: Hardeo K. Panchoosingh - 800-882-4123
Saint Mary's Hospital
West Palm Beach, Florida, United States
Status: Recruiting
Contact: Narayana Gowda - 888-823-5923 - ctsucontact@westat.com
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States
Status: Recruiting
Contact: Howard M. Katzenstein - 800-811-8480
Georgia Regents University
Augusta, Georgia, United States
Status: Recruiting
Contact: Colleen H. McDonough - 706-721-1663 - cancer@georgiahealth.edu
Memorial Health University Medical Center
Savannah, Georgia, United States
Status: Recruiting
Contact: J. M. Johnston - 912-350-8568
Tripler Army Medical Center
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeremy V. Edwards - 808-433-6336
University of Hawaii
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Robert W. Wilkinson - 808-983-6090
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States
Status: Recruiting
Contact: Eugenia Chang - 800-845-4624
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States
Status: Recruiting
Contact: David O. Walterhouse - 773-880-4562
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Status: Recruiting
Contact: Susan L. Cohn - 773-834-7424
University of Illinois
Chicago, Illinois, United States
Status: Recruiting
Contact: Mary L. Schmidt - 312-355-3046
Loyola University Medical Center
Maywood, Illinois, United States
Status: Recruiting
Contact: Ricarchito B. Manera - 708-226-4357
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States
Status: Recruiting
Contact: Sharad N. Salvi - 847-723-7570
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Status: Recruiting
Contact: Jong H. Kwon - 847-384-3621
Saint Jude Midwest Affiliate
Peoria, Illinois, United States
Status: Recruiting
Contact: Pedro A. De Alarcon - 309-655-3258
Memorial Medical Center
Springfield, Illinois, United States
Status: Recruiting
Contact: Gregory P. Brandt - 217-545-7929
Saint John's Hospital
Springfield, Illinois, United States
Status: Recruiting
Contact: Gregory P. Brandt - 217-545-7929
Southern Illinois University
Springfield, Illinois, United States
Status: Recruiting
Contact: Gregory P. Brandt - 217-545-7929
Indiana University Medical Center
Indianapolis, Indiana, United States
Status: Active, not recruiting
Riley Hospital for Children
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Robert J. Fallon - 317-274-2552
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Bassem I. Razzouk - 317-338-2194
Raymond Blank Children's Hospital
Des Moines, Iowa, United States
Status: Recruiting
Contact: Wendy L. Woods-Swafford - 515-241-6729
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Status: Recruiting
Contact: Ayman A. El-Sheikh - 800-237-1225
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States
Status: Recruiting
Contact: Donald B. Wender - 712-252-0088
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States
Status: Recruiting
Contact: Donald B. Wender - 712-252-0088
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States
Status: Recruiting
Contact: Donald B. Wender - 712-252-0088
University of Kentucky
Lexington, Kentucky, United States
Status: Recruiting
Contact: Martha F. Greenwood - 859-257-3379
Kosair Children's Hospital
Louisville, Kentucky, United States
Status: Recruiting
Contact: Salvatore J. Bertolone - 866-530-5516
Children's Hospital-Main Campus
New Orleans, Louisiana, United States
Status: Recruiting
Contact: Lolie C. Yu - 504-894-5377
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Status: Recruiting
Contact: Craig Lotterman - 888-562-4763
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Status: Recruiting
Contact: Tammuella C. Singleton - 504-988-6121
Eastern Maine Medical Center
Bangor, Maine, United States
Status: Recruiting
Contact: Sarah J. Fryberger - 207-973-4274
Johns Hopkins University
Baltimore, Maryland, United States
Status: Recruiting
Contact: David M. Loeb - 410-955-8804 - jhcccro@jhmi.edu
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Status: Recruiting
Contact: Joseph M. Wiley - 410-601-6120 - pridgely@lifebridgehealth.org
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Status: Recruiting
Contact: Teresa A. York - 800-888-8823
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Status: Recruiting
Contact: Anne B. Warwick - 301-319-2100
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Carlos Rodriguez-Galindo - 866-790-4500
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Status: Recruiting
Contact: Carlos Rodriguez-Galindo - 866-790-4500
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Status: Recruiting
Contact: Christopher P. Keuker - 508-856-3216 - cancer.research@umassmed.edu
C S Mott Children's Hospital
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Brenda J. Kitchen - 800-865-1125
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Status: Recruiting
Contact: Hadi Sawaf - 313-343-3166
Wayne State University
Detroit, Michigan, United States
Status: Recruiting
Contact: Roland L. Chu - 313-576-9363
Hurley Medical Center
Flint, Michigan, United States
Status: Recruiting
Contact: Susumu Inoue - 888-606-6556
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States
Status: Recruiting
Contact: David S. Dickens - 616-267-1925
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Status: Recruiting
Contact: Jeffrey S. Lobel - 800-227-2345
Michigan State University - Breslin Cancer Center
Lansing, Michigan, United States
Status: Recruiting
Contact: Renuka Gera - 517-334-2765
Beaumont Children's Hospital-Royal Oak
Royal Oak, Michigan, United States
Status: Terminated
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Bruce C. Bostrom - 612-813-5193
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Brenda J. Weigel - 612-624-2620
Mayo Clinic
Rochester, Minnesota, United States
Status: Recruiting
Contact: Nadia N. Laack - 507-538-7623
University of Mississippi Medical Center
Jackson, Mississippi, United States
Status: Recruiting
Contact: Gail C. Megason - 601-815-6700
Columbia Regional
Columbia, Missouri, United States
Status: Recruiting
Contact: Thomas W. Loew - 573-882-7440
University of Missouri-Columbia
Columbia, Missouri, United States
Status: Withdrawn
The Childrens Mercy Hospital
Kansas City, Missouri, United States
Status: Recruiting
Contact: Maxine L. Hetherington - 816-234-3265
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Bethany G. Sleckman - 913-948-5588
Washington University School of Medicine
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Frederick S. Huang - 800-600-3606 - info@siteman.wustl.edu
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States
Status: Recruiting
Contact: Minnie Abromowitch - 402-955-3949
University of Nebraska Medical Center
Omaha, Nebraska, United States
Status: Recruiting
Contact: Peter F. Coccia - 800-999-5465
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Status: Recruiting
Contact: Nik Farahana N. Rashid - 702-384-0013
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Status: Recruiting
Contact: Sara Chaffee - 800-639-6918 - cancer.research.nurse@dartmouth.edu
Hackensack University Medical Center
Hackensack, New Jersey, United States
Status: Recruiting
Contact: Burton E. Appel - 201-996-2879
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Status: Recruiting
Contact: Stacey Rifkin-Zenenberg - 973-926-7230
Morristown Memorial Hospital
Morristown, New Jersey, United States
Status: Recruiting
Contact: Steven L. Halpern - 973-971-5900
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
Status: Recruiting
Contact: Stanley Calderwood - 732-745-8600 - kcovert@saintpetersuh.com
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Status: Recruiting
Contact: Richard A. Drachtman - 732-235-8675
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Status: Recruiting
Contact: Peri Kamalakar - 973-926-7230
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States
Status: Recruiting
Contact: Mary A. Bonilla - 973-754-2909
Overlook Hospital
Summit, New Jersey, United States
Status: Recruiting
Contact: Steven L. Halpern - 973-971-5900
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Status: Recruiting
Contact: Koh B. Boayue - 505-272-6972
Albany Medical Center
Albany, New York, United States
Status: Recruiting
Contact: Vikramjit S. Kanwar - 518-262-3368
Montefiore Medical Center
Bronx, New York, United States
Status: Recruiting
Contact: Rosanna J. Ricafort - 718-904-2730 - aecc@aecom.yu.edu
Roswell Park Cancer Institute
Buffalo, New York, United States
Status: Recruiting
Contact: Martin L. Brecher - 877-275-7724
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
Status: Recruiting
Contact: Carolyn F. Levy - 718-470-3470
Columbia University Medical Center
New York, New York, United States
Status: Recruiting
Contact: Alice Lee - 212-305-8615
Mount Sinai Medical Center
New York, New York, United States
Status: Recruiting
Contact: Birte Wistinghausen - 212-824-7320 - jenny.figueroa@mssm.edu
New York University Langone Medical Center
New York, New York, United States
Status: Recruiting
Contact: Elizabeth A. Raetz - 212-263-4434 - prmc.coordinator@nyumc.org
University of Rochester
Rochester, New York, United States
Status: Recruiting
Contact: Lisa R. Hackney - 585-275-5830
Stony Brook University Medical Center
Stony Brook, New York, United States
Status: Recruiting
Contact: Robert I. Parker - 800-862-2215
State University of New York Upstate Medical University
Syracuse, New York, United States
Status: Recruiting
Contact: Karol H. Kerr - 315-464-5476
Ny Cancer%
Valhalla, New York, United States
Status: Recruiting
Contact: Mehmet F. Ozkaynak - 914-594-3794
Mission Hospitals
Asheville, North Carolina, United States
Status: Recruiting
Contact: Krystal S. Bottom - 828-213-4150
University of North Carolina
Chapel Hill, North Carolina, United States
Status: Recruiting
Contact: Stuart H. Gold - 877-668-0683 - cancerclinicaltrials@med.unc.edu
Carolinas Medical Center
Charlotte, North Carolina, United States
Status: Recruiting
Contact: Joel A. Kaplan - 704-355-2884
Presbyterian Hospital
Charlotte, North Carolina, United States
Status: Recruiting
Contact: Paulette C. Bryant - 704-384-5369
Duke University Medical Center
Durham, North Carolina, United States
Status: Recruiting
Contact: Susan G. Kreissman - 888-275-3853
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Status: Recruiting
Contact: Thomas W. McLean - 336-713-6771
Sanford Medical Center-Fargo
Fargo, North Dakota, United States
Status: Recruiting
Contact: Nathan L. Kobrinsky - 701-234-6161
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Status: Recruiting
Contact: Steven J. Kuerbitz - 330-543-3193
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Status: Recruiting
Contact: John P. Perentesis - 513-636-2799
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Status: Recruiting
Contact: Margaret C. Thompson - 866-223-8100
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States
Status: Recruiting
Contact: Yousif (Joe) H. Matloub - 216-844-5437
Nationwide Children's Hospital
Columbus, Ohio, United States
Status: Recruiting
Contact: Mark A. Ranalli - 614-722-2708
The Children's Medical Center of Dayton
Dayton, Ohio, United States
Status: Recruiting
Contact: Emmett H. Broxson - 800-228-4055
Mercy Children's Hospital
Toledo, Ohio, United States
Status: Recruiting
Contact: Rama Jasty - 419-251-8210
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
Status: Recruiting
Contact: Dagmar T. Stein - 419-824-1842
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Status: Recruiting
Contact: Rene Y. McNall-Knapp - 405-271-4272 - julie-traylor@ouhsc.edu
Natalie W Bryant Cancer Center
Tulsa, Oklahoma, United States
Status: Recruiting
Contact: Gregory B. Kirkpatrick - 918-494-2200
Legacy Emanuel Children's Hospital
Portland, Oregon, United States
Status: Recruiting
Contact: Janice F. Olson - 503-413-2560
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Status: Recruiting
Contact: Janice F. Olson - 503-413-2560
Oregon Health and Science University
Portland, Oregon, United States
Status: Recruiting
Contact: Suman Malempati - 503-494-1080 - trials@ohsu.edu
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Status: Recruiting
Contact: Philip M. Monteleone - 484-884-2201
Geisinger Medical Center
Danville, Pennsylvania, United States
Status: Recruiting
Contact: Jeffrey S. Taylor - 570-271-5251
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States
Status: Recruiting
Contact: Lisa M. McGregor - 717-531-6012
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Margaret von Mehren - 215-728-4790
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Gregory E. Halligan - 215-427-8991
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Michael R. Wollman - 412-692-5573
Rhode Island Hospital
Providence, Rhode Island, United States
Status: Recruiting
Contact: Cindy L. Schwartz - 401-444-1488
Medical University of South Carolina
Charleston, South Carolina, United States
Status: Recruiting
Contact: Jacqueline M. Kraveka - 843-792-9321
Palmetto Health Richland
Columbia, South Carolina, United States
Status: Recruiting
Contact: Ronnie W. Neuberg - 803-434-3680
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States
Status: Recruiting
Contact: Nichole L. Bryant - 864-241-6251
Greenville Cancer Treatment Center
Greenville, South Carolina, United States
Status: Recruiting
Contact: Cary E. Stroud - 864-241-6251
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Status: Recruiting
Contact: Kayelyn J. Wagner - 605-328-1367
T C Thompson Children's Hospital
Chattanooga, Tennessee, United States
Status: Recruiting
Contact: Donald H. Chamberlain - 423-698-2050
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States
Status: Recruiting
Contact: Ray C. Pais - 865-541-8266
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Status: Recruiting
Contact: Wayne L. Furman - 901-595-4644
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Scott C. Borinstein - 800-811-8480
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
Status: Recruiting
Contact: Sharon K. Lockhart - 512-324-8022
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Status: Recruiting
Contact: M. C. Johnson - 361-694-5311
Medical City Dallas Hospital
Dallas, Texas, United States
Status: Recruiting
Contact: Carl Lenarsky - 972-566-5588
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Status: Recruiting
Contact: Naomi J. Winick - 214-648-7097
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Status: Recruiting
Contact: Della L. Howell - 210-292-7311
Cook Children's Medical Center
Fort Worth, Texas, United States
Status: Recruiting
Contact: Mary Meaghan P. Granger - 682-885-2103
Baylor College of Medicine
Houston, Texas, United States
Status: Recruiting
Contact: Lisa R. Bomgaars - 713-798-1354 - burton@bcm.edu
M D Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Cynthia E. Herzog - cherzog@mdanderson.org
M D Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Najat C. Daw - 713-792-3245
Covenant Children's Hospital
Lubbock, Texas, United States
Status: Recruiting
Contact: Latha Prasannan - 806-725-8000 - jaccresearch@covhs.org
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Status: Recruiting
Contact: Anne-Marie R. Langevin - 210-567-0653 - che@uthscsa.edu
Scott and White Memorial Hospital
Temple, Texas, United States
Status: Recruiting
Contact: Guy H. Grayson - 254-724-5407
Primary Children's Medical Center
Salt Lake City, Utah, United States
Status: Recruiting
Contact: Phillip E. Barnette - 801-585-5270
University of Vermont
Burlington, Vermont, United States
Status: Recruiting
Contact: Alan C. Homans - 802-656-8990
University of Virginia
Charlottesville, Virginia, United States
Status: Recruiting
Contact: Kimberly P. Dunsmore - 434-243-6143
Inova Fairfax Hospital
Falls Church, Virginia, United States
Status: Recruiting
Contact: Marshall A. Schorin - 703-208-6650
Childrens Hospital-King's Daughters
Norfolk, Virginia, United States
Status: Recruiting
Contact: Eric J. Lowe - 757-668-7243
Virginia Commonwealth University
Richmond, Virginia, United States
Status: Recruiting
Contact: Kamar Godder - 305-662-8360
Seattle Children's Hospital
Seattle, Washington, United States
Status: Recruiting
Contact: Douglas S. Hawkins - 866-987-2000
University of Washington Medical Center
Seattle, Washington, United States
Status: Recruiting
Contact: Douglas S. Hawkins - 866-987-2000
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
Status: Recruiting
Contact: Judy L. Felgenhauer - 800-228-6618 - HopeBeginsHere@providence.org
Madigan Army Medical Center
Tacoma, Washington, United States
Status: Recruiting
Contact: Melissa A. Forouhar - 253-968-0129 - mamcdci@amedd.army.mil
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States
Status: Recruiting
Contact: Robert G. Irwin - 888-823-5923 - ctsucontact@westat.com
West Virginia University Charleston
Charleston, West Virginia, United States
Status: Recruiting
Contact: Allen R. Chauvenet - 304-388-9944
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Status: Recruiting
Contact: Kenneth B. DeSantes - 608-262-5223
Marshfield Clinic
Marshfield, Wisconsin, United States
Status: Recruiting
Contact: Michael J. McManus - 715-389-4457
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Status: Recruiting
Contact: Timothy S. Fenske - 414-805-4380
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Status: Recruiting
Contact: Meghen B. Browning - 414-805-4380
Sydney Children's Hospital
Randwick, New South Wales, Australia
Status: Recruiting
Contact: Draga Barbaric - (02) 9382-1721
The Children's Hospital at Westmead
Sydney, New South Wales, Australia
Status: Recruiting
Contact: Geoffrey B. McCowage - 61-2-9845 1400
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Status: Recruiting
Contact: Helen Irving - 888-823-5923 - ctsucontact@westat.com
Royal Childrens Hospital
Herston, Queensland, Australia
Status: Recruiting
Contact: Helen Irving - 888-823-5923 - ctsucontact@westat.com
Women's and Children's Hospital-Adelaide
North Adelaide, South Australia, Australia
Status: Recruiting
Contact: Maria L. Kirby - (08) 8161 7327 - cywhs.oncsec@health.sa.gov.au
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Status: Recruiting
Contact: Catherine H. Cole - (08) 9340 8330 - admin@childcancerresearch.com.au
Alberta Children's Hospital
Calgary, Alberta, Canada
Status: Recruiting
Contact: Douglas R. Strother - 403-220-6898 - research4kids@ucalgary.ca
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Status: Recruiting
Contact: Caron Strahlendorf - 604-875-2345ext6477
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Status: Recruiting
Contact: Rochelle A. Yanofsky - 866-561-1026 - CIO_Web@cancercare.mb.ca
Janeway Child Health Centre
Saint John's, Newfoundland and Labrador, Canada
Status: Recruiting
Contact: Lisa Anne B. Goodyear - 866-722-1126
IWK Health Centre
Halifax, Nova Scotia, Canada
Status: Recruiting
Contact: Margaret C. Yhap - 902-470-8394
Chedoke-McMaster Hospitals
Hamilton, Ontario, Canada
Status: Recruiting
Contact: Carol Portwine - 905-521-2100ext74595
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Status: Recruiting
Contact: Carol Portwine - 905-521-2100ext74595
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Status: Recruiting
Contact: Mariana P. Silva - 613-544-2630
Children's Hospital
London, Ontario, Canada
Status: Recruiting
Contact: Anne E. Cairney - 519-685-8306
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Status: Recruiting
Contact: Jacqueline M. Halton - 613-738-3931
Hospital for Sick Children
Toronto, Ontario, Canada
Status: Recruiting
Contact: Abha A. Gupta - 416-946-4501 - clinical.trials@uhn.on.ca
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Status: Recruiting
Contact: Yvan Samson - 514-345-4931
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada
Status: Recruiting
Contact: Sharon B. Abish - 514-412-4445 - info@thechildren.com
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, Canada
Status: Recruiting
Contact: Bruno Michon - 418-525-4444
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Status: Recruiting
Contact: Mansoor M. Haq - 306-766-2213
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Status: Recruiting
Contact: Christopher Mpofu - 306-655-2914
Starship Children's Hospital
Grafton, Auckland, New Zealand
Status: Recruiting
Contact: Lochie R. Teague - 0800 728 436
Christchurch Hospital
Christchurch, New Zealand
Status: Recruiting
Contact: Siobhan F. Cross - 03 364 0640
San Jorge Children's Hospital
Santurce, Puerto Rico
Status: Recruiting
Contact: Luis A. Clavell - 888-823-5923 - ctsucontact@westat.com
Start Date
November 2010
Sponsors
Children's Oncology Group
Source
Children's Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page