Risk-Adapted Chemotherapy in Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive care, TreatmentActive1 to < 10NCI, OtherAALL0932
NCI-2011-02599, CDR0000683227, U10CA098543, COG-AALL0932, NCT01190930

Trial Description

Summary

This partially randomized phase III clinical trial is studying different combinations of risk-adapted chemotherapy regimens and their side effects and comparing how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.

Further Study Information

PRIMARY OBJECTIVES:

l. To determine if a maintenance regimen containing once weekly oral methotrexate at 40 mg/m^2/week will result in an improved disease-free survival (DFS) compared to that containing weekly oral methotrexate at 20 mg/m^2/week in the average-risk (AR) subset of pediatric patients with standard-risk (SR) B-precursor acute lymphoblastic leukemia (ALL).

II. To determine whether a reduced-pulses maintenance regimen with vincristine sulfate/dexamethasone pulses delivered every 12 weeks can be used without adversely impacting DFS as compared to pulses given every 4 weeks in the AR subset of patients with SR B-precursor ALL.

III. To confirm that patients in the low-risk (LR) subset of SR B-precursor ALL, based on clinical and cytogenetic features and minimal residual disease (MRD) criteria, can attain a 5-year DFS of at least 95% with either a P9904-based regimen that includes 6 courses of intermediate dose (1 g/m^2 over 24 hours) methotrexate without alkylating agents or anthracyclines (Arm LR-M), or an outpatient-based regimen identical to that of AR patients with reduced vincristine sulfate/dexamethasone pulses at 12-week intervals during maintenance (Arm LR-C).

IV. To provide standardized treatment and enhanced supportive care to children with SR Down syndrome-ALL in order to improve outcomes and facilitate further study of this biologically and clinically unique patient subgroup.

V. To improve understanding of the biology of localized B-LLy and DS B-LLy by obtaining biologic data, including FISH for recurrent cytogenetic lesions on paraffin specimen, and banking tissue for future research.

VI. To describe the 5-year EFS and overall survival (OS) of patients with Murphy Stage I and II B-LLy receiving modified AR B-ALL therapy.

SECONDARY OBJECTIVES:

I. To assess the burden of AR-ALL therapy as measured by surveys of the child's quality of life, missed days of school/daycare/work by children and parents, family functioning, parental perception of the child's health vulnerability, physical functioning, and emotional distress overall at different time points during and at the end of therapy.

II. To assess the burden of AR-ALL therapy as measured by surveys of the child's quality of life, missed days of school/daycare/work by children and parents, family functioning, parental perception of the child's health vulnerability, physical functioning, and emotional distress by comparing children randomized to every 4-week vs every 12-week dexamethasone/vincristine sulfate pulses during maintenance therapy.

III. To characterize the onset, severity, and natural history of vincristine associated neuropathy by physical therapists (or occupational therapists) in children undergoing therapy for AR-ALL, 1) overall at different time points during and at the end of therapy, and by 2) comparing children randomized to every 4 week vs. every 12 week dexamethasone/vincristine pulses during Maintenance.

IV. To characterize the onset, severity, and natural history of vincristine associated neuropathy by physical therapists (or occupational therapists) in children undergoing therapy for AR B-ALL, 1) overall at different time points during and at the end of therapy, and by 2) comparing children randomized to every 4 week vs. every 12 week dexamethasone/vincristine pulses during Maintenance.

V. To explore the correlation of minimal marrow disease (MMD) at diagnosis and outcome for patients with B-LLy.

OUTLINE: This is a multicenter study.

All patients receive induction therapy comprising intrathecal (IT) cytarabine on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally or IV twice daily (BID) on days 1-28; pegaspargase IV over 1-2 hours on day 4; and IT methotrexate* on days 8 and 29. Patients with Philadelphia chromosome-positive disease are eligible to transfer to COG-AALL0622 by day 15 of induction therapy and patients with high-risk (HR) or very high-risk (VHR) disease are eligible to transfer to a COG HR or VHR trial at the end of induction therapy. Patients with standard-risk disease with Down syndrome (DS) who have bone marrow minimal residual disease 0.01% are eligible to transfer to the DS stratum of the HR trial. Patients with induction failure (defined as M3 [> 25% lymphoblasts] on day 29) may be eligible for the COG VHR-acute lymphoblastic leukemia study.

NOTE: *Patients with DS also receive oral leucovorin calcium every 12 hours on days 10-11 and 31-32.

STANDARD-RISK WITH DOWN SYNDROME:

Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; oral mercaptopurine on days 1-28; IT methotrexate on days 1, 8, and 15; and oral leucovorin calcium every 12 hours on days 3-4, 10-11, and 17-18. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on day 31; and oral leucovorin calcium every 12 hours on days 36-34. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone orally or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; oral thioguanine on days 29-42; cytarabine IV over 1-15 minutes or subcutaneously (SC) on days 29-32 and 33-39; IT methotrexate on days 1 and 29; and oral leucovorin calcium every 12 hours on days 3-4 and 31-32. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on days 1 and 31; and oral leucovorin calcium every 12 hours on days 3-4 and 33-34. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; oral dexamethasone BID on days 1-5; oral methotrexate on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; oral mercaptopurine on days 1-84; and IT methotrexate on day 1. Courses repeat every 12 weeks for 2 years (timed from the start of interim maintenance I therapy).

AVERAGE-RISK:

Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; oral mercaptopurine on days 1-28; and IT methotrexate on days 1, 8, and 15.Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on day 31. Delayed intensification therapy (8 weeks): Patients receive dexamethasone orally or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; oral thioguanine on days 29-42; cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39; and IT methotrexate on days 1 and 29. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on days 1 and 31. Maintenance therapy: Patients are randomized to 1 of 4 maintenance therapy treatment arms.

Arm A: Patients receive vincristine sulfate IV on days 1, 29, and 57; oral dexamethasone BID on days 1-5, 29-33, and 57-61; oral methotrexate on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; oral mercaptopurine on days 1-84; and IT methotrexate on day 1.

Arm B: Patients receive vincristine sulfate IV on days 1, 29, and 57; oral dexamethasone BID on days 1-5, 29-33, and 57-61; higher-dose oral methotrexate on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; oral mercaptopurine on days 1-84; and IT methotrexate on day 1.

Arm C: Patients receive vincristine sulfate IV on day 1; oral dexamethasone BID on days 1-5; oral methotrexate on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; oral mercaptopurine on days 1-84; and IT methotrexate on day 1.

Arm D: Patients receive vincristine sulfate IV on day 1; oral dexamethasone BID on days 1-5; higher-dose oral methotrexate on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; oral mercaptopurine on days 1-84; and IT methotrexate on day 1.

In all arms, maintenance therapy courses repeat every 12 weeks for 2 years for girls and for 3 years for boys (timed from the start of interim maintenance I therapy).

LOW-RISK: Patients are randomized to 1 of 2 treatment arms.

Arm I (LR-M): Consolidation therapy (19 weeks): Beginning one week after completion of induction therapy, patients receive vincristine sulfate IV on days 15, 22, 78, and 85; methotrexate IV over 24 hours and IT methotrexate on days 8, 29, 50, 71, 92, and 113; leucovorin calcium orally or IV on days 9-10, 30-31, 51-52, 72-73, 93-94, and 114-115; dexamethasone orally or IV BID on days 15-21 and 78-84; and oral mercaptopurine on days 1-133.Maintenance therapy: Patients receive vincristine sulfate IV on days 1 and 8; oral dexamethasone BID on days 1-7; oral methotrexate* on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, and 106; and oral mercaptopurine on days 1-112. Courses repeat every 16 weeks. Patients also receive IT methotrexate on days 1 and 85 (courses 1 and 4), day 57 (courses 2 and 5), or day 29 (courses 3 and 6). Patients then receive course 7 comprising vincristine sulfate IV on days 1 and 8; oral dexamethasone BID on days 1-7; oral methotrexate on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64; and oral mercaptopurine on days 1-70. Treatment continues for 2 and ½ years (timed from the date of diagnosis).NOTE: *Patients do not receive oral methotrexate on the days that they receive IT methotrexate.

Arm II (LR-C): Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; oral mercaptopurine on days 1-28; and IT methotrexate on days 1, 8, and 15. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on day 31. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone orally or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; oral thioguanine on days 29-42; cytarabine IV over 1-15 minutes or SC on days 29-32 and 36-39; and IT methotrexate on days 1 and 29.Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on days 1 and 31. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; oral dexamethasone BID on days 1-5; oral methotrexate on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; oral mercaptopurine on days 1-84; and IT methotrexate on day 1. Courses repeat every 12 weeks for 2 years for girls and for 3 years for boys (timed from the start of interim maintenance I therapy).

Blood samples may be collected periodically for research studies and patients may complete quality-of-life surveys periodically.

After completion of study treatment, patients are followed up periodically for 10 years.

Eligibility Criteria

Inclusion Criteria:

  • B-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0932
  • Patients must have newly diagnosed NCI Standard Risk B-ALL or B-LLy Murphy Stages I or II; patients with Down syndrome are also eligible
  • Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted
  • Meets the criteria for one of the following risk groups after induction therapy
  • Low-risk (LR) disease, defined as meeting the following criteria:
  • Favorable genetics: the presence of simultaneous trisomies of chromosome 4 and 10 (double trisomy; DT) or ETV6/RUNX1 fusion
  • Day 8 peripheral blood (PB) minimal residual disease (MRD) < 0.01%
  • Day 29 bone marrow (BM) MRD < 0.01%
  • No CNS2*, CNS3*, or testicular† leukemia
  • No steroid pretreatment
  • No Down syndrome (DS)
  • Average-risk disease, defined as meeting one of the following sets of criteria:
  • Favorable genetics: the presence of DT or ETV6/RUNX1 fusions
  • Day 8 PB MRD ≥ 0.01% or CNS2* status
  • Day 29 BM MRD < 0.01%
  • No CNS3* or testicular† leukemia
  • No DS
  • Neither favorable nor unfavorable cytogenetics‡
  • Day 8 PB MRD < 1%
  • Day 29 BM MRD < 0.01%
  • No CNS3* or testicular† leukemia
  • No DS
  • Standard-risk with Down syndrome (DS), defined as meeting the following criteria:
  • No mixed-lineage leukemia (MLL)-rearrangement, hypodiploidy**, or Philadelphia chromosome-positive (Ph+) disease††
  • Day 29 BM MRD < 0.01%‡‡
  • No CNS3* or testicular† leukemia
  • WBC count < 50,000/mm^3
  • No prior cytotoxic chemotherapy for the current diagnosis of ALL or any cancer diagnosed previously
  • Steroids* and intrathecal cytarabine for the current diagnosis of ALL allowed
  • Inhalational steroids are not considered as pretreatment
  • Patients with testicular leukemia are not eligible for AALL0932

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

  • National Cancer Institute
Anne Angiolillo, MD, Principal Investigator
Peter Adamson, MD
Ph: 612-624-8651
Email: Adamson@email.chop.edu

Trial Sites

U.S.A.

Alabama
Birmingham

Children's Hospital of Alabama at University of Alabama at Birmingham

Alyssa T Reddy
Ph: 888-823-5923
Email: ctsucontact@westat.com

Alaska
Anchorage

Providence Cancer Center

Brenda J Wittman
Ph: 907-261-3109

Arizona
Mesa

Cardon Children's Medical Center

Xiaxin Li
Ph: 602-747-9738

Phoenix

Phoenix Children's Hospital

Jessica Boklan
Ph: 602-546-0920

Tucson

Arizona Cancer Center at University of Arizona Health Sciences Center

Lisa M Kopp
Ph: 520-626-9008

Arkansas
Little Rock

Arkansas Children's Hospital at the 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

Anne Angiolillo

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

Theodore Zwerdling
Ph: 562-933-5600

Los Angeles

Children's Hospital Los Angeles

Leo Mascarenhas
Ph: 323-361-4110

Jonsson Comprehensive Cancer Center at UCLA

Pamela H Kempert
Ph: 310-825-6708

Mattel Children's Hospital at UCLA

Pamela H Kempert
Ph: 310-825-6708

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Fataneh (Fae) Majlessipour
Ph: 310-423-8965

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

Kaiser Permanente-Oakland

Steven K Bergstrom
Ph: 626-564-3455

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

Sutter Cancer Center

Yung S Yim
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

University of California Davis Cancer Center

Jay Michael S Balagtas
Ph: 916-734-3089

San Diego

Naval Medical Center - San Diego

Joanne F McManaman
Ph: 619-532-8712

Rady Children's Hospital - San Diego

William D Roberts
Ph: 858-966-5934

San Francisco

UCSF Helen Diller Family Comprehensive Cancer Center

Mignon Loh
Ph: 877-827-3222

Santa Barbara

Santa Barbara Cottage Hospital

Daniel J Greenfield
Ph: 805-682-7300

Torrance

Los Angeles Biomedical Research Institute

Joseph L Lasky
Ph: 888-662-8252

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

Jeffrey H Schwartz
Ph: 904-697-3529

District of Columbia
Washington

Children's National Medical Center

Jeffrey S Dome
Ph: 202-884-2549

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Aziza T Shad
Ph: 202-444-0381

Florida
Fort Lauderdale

Broward General Medical Center Cancer Center

Hector M Rodriguez-Cortes
Ph: 954-355-5346

Fort Myers

Children's Hospital of Southwest Florida

Emad K Salman
Ph: 239-343-5333

Gainesville

UF Health Cancer Center

William B Slayton
Ph: 352-273-8675
Email: trials@cancer.ufl.edu

Hollywood

Joe DiMaggio Children's Hospital

Iftikhar Hanif
Ph: 954-265-2234

Jacksonville

Nemours Children's Clinic

Jeffrey H Schwartz
Ph: 904-697-3529

Miami

Baptist-South Miami Regional Cancer Program

Doured Daghistani
Ph: 800-599-2456
Email: cancerinfo@baptisthealth.net

Miami Children's Hospital

Enrique A Escalon
Ph: 305-662-8360

University of Miami Sylvester Comprehensive Cancer Center - Miami

Julio C Barredo
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Orlando

Arnold Palmer Hospital for Children

Vincent F Giusti
Ph: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com

Florida Hospital Cancer Institute at Florida Hospital Orlando

Fouad M Hajjar
Ph: 407-303-5623

Nemours Children's Hospital

Jeffrey H Schwartz
Ph: 904-697-3529

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

Erin M Cockrell
Ph: 800-882-4123

Tampa General Hospital

Cameron K Tebbi
Ph: 800-882-4123
Email: hkourtellis@tgh.org

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

Frank G Keller
Ph: 888-785-1112

Augusta

Medical College of Georgia Cancer Center

Colleen H McDonough
Ph: 706-721-1663
Email: cancer@georgiahealth.edu

Savannah

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

J. M Johnston
Ph: 912-350-8568

Hawaii
Honolulu

Kapiolani Medical Center for Women and Children

Robert W Wilkinson
Ph: 808-983-6090

Tripler Army Medical Center

Tonya M Kratovil
Ph: 808-433-6336

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

Elaine R Morgan
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: 847-723-7570

Oak Lawn

Keyser Family Cancer Center at Advocate Hope Children's Hospital

Rebecca E McFall
Ph: 847-723-7570

Park Ridge

Advocate Children's Hospital-Park Ridge

Jong-Hyo Kwon
Ph: 847-384-3621

Peoria

Saint Jude Midwest Affiliate

Karen S Fernandez
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: 888-823-5923
Email: ctsucontact@westat.com

St. Vincent Indianapolis Hospital

Bassem I Razzouk
Ph: 317-338-2194

Iowa
Des Moines

Blank Children's Hospital

Wendy L Woods-Swafford
Ph: 515-241-6729

Iowa City

Holden Comprehensive Cancer Center at University of Iowa

Ayman A El-Sheikh
Ph: 800-237-1225

Kentucky
Lexington

University of Kentucky Chandler Medical Center

Lars M Wagner
Ph: 859-257-3379

Louisville

Kosair Children's Hospital

Kenneth G Lucas
Ph: 866-530-5516

Louisiana
New Orleans

Children's Hospital of New Orleans

Lolie C Yu
Ph: 504-894-5377

Ochsner Cancer Institute at Ochsner Clinic Foundation

Craig Lotterman
Ph: 888-562-4763

Maine
Bangor

CancerCare of Maine at Eastern Maine Medical Center

Sam W Lew
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

Greenebaum Cancer Center at University of Maryland Medical Center

Teresa A York
Ph: 800-888-8823

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Patrick A Brown
Ph: 410-955-8804
Email: jhcccro@jhmi.edu

Bethesda

National Naval Medical Center

Anne B Warwick
Ph: 301-319-2100

Massachusetts
Boston

Floating Hospital for Children at Tufts - New England Medical Center

Michael J Kelly
Ph: 617-636-5000
Email: ContactUsCancerCenter@TuftsMedicalCenter.org

Massachusetts General Hospital

Howard J Weinstein
Ph: 877-726-5130

Springfield

Baystate Medical Center

Joanna G Luty
Ph: 413-794-3565
Email: tamara.wrenn@baystatehealth.org

Worcester

UMASS Memorial Cancer Center - University Campus

Christopher P Keuker
Ph: 508-856-3216
Email: cancer.research@umassmed.edu

Michigan
Ann Arbor

C.S. Mott Children's Hospital at University of Michigan Medical Center

Raymond J Hutchinson
Ph: 800-865-1125

Detroit

Van Elslander Cancer Center at St. John Hospital and Medical Center

Hadi Sawaf
Ph: 313-343-3166

Wayne State University

Jeffrey W Taub
Ph: 313-576-9363

East Lansing

Breslin Cancer Center at Ingham Regional Medical Center

Renuka Gera
Ph: 517-975-9547

Flint

Hurley Medical Center

Susumu Inoue
Ph: 888-606-6556

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

Royal Oak

William Beaumont Hospital - Royal Oak Campus

Laura K Gowans
Ph: 248-551-7695

Minnesota
Minneapolis

Children's Hospitals and Clinics of Minnesota - Minneapolis

Bruce C Bostrom
Ph: 612-813-5193

Masonic Cancer Center at University of Minnesota

Peter M Gordon
Ph: 612-624-2620

Rochester

Mayo Clinic Cancer Center

Vilmarie Rodriguez
Ph: 507-538-7623

Mississippi
Jackson

University of Mississippi Cancer Clinic

Gail C Megason
Ph: 601-815-6700

Missouri
Columbia

Columbia Regional Hospital

Thomas W Loew
Ph: 573-882-7440

Kansas City

Children's Mercy Hospital

Maxine L Hetherington
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

Fred and Pamela Buffett Cancer Center

Minnie Abromowitch
Ph: 402-955-3949

Nevada
Las Vegas

Cancer Institute of Nevada at Summerlin Hospital Medical Center

Jonathan Bernstein
Ph: 702-384-0013

CCOP - Nevada Cancer Research Foundation

Jonathan Bernstein
Ph: 702-384-0013

Children's Specialty Center of Nevada

Jonathan Bernstein
Ph: 702-384-0013

Sunrise Hospital and Medical Center

Nik Farahana N Rashid
Ph: 702-384-0013

University Medical Center of Southern Nevada

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

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

Anne Angiolillo

New York
Albany

Albany Medical Center Hospital

Vikramjit S Kanwar
Ph: 518-262-3368

Bronx

Montefiore Medical Center

Peter D Cole
Ph: 718-904-2730
Email: aecc@aecom.yu.edu

Buffalo

Roswell Park Cancer Institute

Barbara J Bambach
Ph: 877-275-7724

Mineola

Winthrop University Hospital

Mark E Weinblatt
Ph: 866-946-8476

New Hyde Park

Schneider Children's Hospital

Arlene S Redner
Ph: 718-470-3470

New York

Memorial Sloan-Kettering Cancer Center

Peter G Steinherz
Ph: 212-639-7202

Mount Sinai Medical Center

Birte Wistinghausen
Ph: 212-824-7320
Email: jenny.figueroa@mssm.edu

New York University Medical Center

Linda Granowetter
Ph: 212-263-4434
Email: prmc.coordinator@nyumc.org

New York Weill Cornell Cancer Center at Cornell University

Alexander Aledo
Ph: 212-746-1848

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

Valhalla

New York Medical College

Jessica C Hochberg
Ph: 914-594-3794

North Carolina
Asheville

Mission Hospitals - Memorial Campus

Douglas J Scothorn
Ph: 828-213-4150

Chapel Hill

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Stuart H Gold
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Charlotte

Presbyterian Cancer Center at Presbyterian Hospital

Paulette C Bryant
Ph: 704-384-5369

Durham

Duke Cancer Institute

Susan G Kreissman
Ph: 888-275-3853

Greenville

Leo W. Jenkins Cancer Center at ECU Medical School

George E Hucks
Ph: 252-744-2391

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

Samuel O Anim
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

Jamie L Dargart
Ph: 419-824-1842

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

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

Susan J Lindemulder
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
Bethlehem

Lehigh Valley Hospital - Muhlenberg

Philip M Monteleone
Ph: 484-884-2201

Danville

Geisinger Cancer Institute at Geisinger Health

Jagadeesh Ramdas
Ph: 570-271-5251

Hershey

Penn State Children's Hospital

Lisa M McGregor
Ph: 717-531-6012

Philadelphia

Children's Hospital of Philadelphia

Susan R Rheingold
Ph: 215-590-2810

Children's Oncology Group

Anne Angiolillo
Ph: 202-884-2549
Email: aangioli@cnmc.org

St. Christopher's Hospital for Children

Gregory E Halligan
Ph: 215-427-8991

Pittsburgh

Children's Hospital of Pittsburgh of UPMC

Arthur K Ritchey
Ph: 412-692-5573

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

Nichole L Bryant
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

Jeffrey E Rubnitz
Ph: 866-278-5833
Email: info@stjude.org

Nashville

Vanderbilt-Ingram Cancer Center

Howard M Katzenstein
Ph: 800-811-8480

Texas
Austin

Dell Children's Medical Center of Central Texas

Amy C Fowler
Ph: 214-648-7097

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

Tamra L Slone
Ph: 214-648-7097

El Paso

El Paso Children's Hospital

Lisa L Hartman
Ph: 888-823-5923
Email: ctsucontact@westat.com

Fort Worth

Cook Children's Medical Center - Fort Worth

Kenneth M Heym
Ph: 682-885-2103

Houston

Dan L. Duncan Cancer Center at Baylor College of Medicine

Karen R Rabin
Ph: 713-798-1354
Email: burton@bcm.edu

Univeristy of Texas M.D. Anderson Cancer Center

Cesar A Nunez
Ph: 713-792-3245

Lubbock

Covenant Children's Hospital

Latha Prasannan
Ph: 806-725-8000
Email: jaccresearch@covhs.org

McAllen

Vannie E. Cook Jr. Children's Cancer and Hematology Clinic

Juan C Bernini
Ph: 713-798-1354
Email: burton@bcm.edu

San Antonio

Children's Hospital of San Antonio

Timothy C Griffin
Ph: 713-798-1354
Email: burton@bcm.edu

Methodist Children's Hospital of South Texas

Jaime Estrada
Ph: 210-575-7000

University of Texas Health Science Center at San Antonio

Anne-Marie R Langevin
Ph: 210-450-3800
Email: CTO@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

University of Vermont Cancer Center

Alan C Homans
Ph: 802-656-4101

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

Portsmouth

Naval Medical Center - Portsmouth

Bethany M Mikles
Ph: 757-953-5939

Richmond

Virginia Commonwealth University Massey Cancer Center

Gita V Massey
Ph: 804-628-1939

Roanoke

Carilion Medical Center for Children at Roanoke Community Hospital

Mandy M Atkinson
Ph: 540-981-7376

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

Madigan Army Medical Center - Tacoma

Melissa A Forouhar
Ph: 253-968-0129
Email: mamcdci@amedd.army.mil

Mary Bridge Children's Hospital and Health Center - Tacoma

Robert G Irwin
Ph: 253-403-3229

West Virginia
Charleston

West Virginia University Medical School - Charleston

Howard M Grodman
Ph: 304-388-9944

Morgantown

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Stephan R Paul
Ph: 304-293-2745
Email: sfilburn@hsc.wvu.edu

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 DeSantes
Ph: 608-262-5223

Marshfield

Marshfield Clinic - Marshfield Center

Michael J McManus
Ph: 715-389-4457

Milwaukee

Midwest Children's Cancer Center at Children's Hospital of Wisconsin

Michael E Kelly
Ph: 414-805-4380

Australia

New South Wales
Hunter Regional Mail Centre

John Hunter Hospital

Elizabeth L Hesketh
Ph: 888-823-5923
Email: ctsucontact@westat.com

Queensland
Herston

Royal Brisbane and Women's Hospital

Helen Irving
Ph: 888-823-5923
Email: ctsucontact@westat.com

South Brisbane

Lady Cilento Children's Hospital

Helen Irving
Ph: 888-823-5923
Email: ctsucontact@westat.com

Victoria
Clayton

Monash Medical Center - Clayton Campus

Peter A Downie
Ph: 888-823-5923
Email: ctsucontact@westat.com

Parkville

Royal Children's Hospital

Francoise M Mechinaud
Email: crdo.info@mcri.edu.au

Western Australia
Perth

Princess Margaret Hospital for Children

Catherine H Cole
Ph: (08) 9340 8222
Email: catherine.cole@health.wa.gov.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
Kingston

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Mariana P Silva
Ph: 613-544-2630

London

Children's Hospital of Western Ontario

Shayna M Zelcer
Ph: 519-685-8306

Ottawa

Children's Hospital of Eastern Ontario

Jacqueline M Halton
Ph: 613-738-3931

Toronto

Hospital for Sick Children

Johann H Hitzler
Ph: 416-813-7654ext2027
Email: jason.mcguire@sickkids.ca

Quebec
Montreal

Montreal Children's Hospital at McGill University Health Center

Sharon B Abish
Ph: 514-412-4445
Email: info@thechildren.com

Saskatchewan
Saskatoon

Saskatoon Cancer Centre at the University of Saskatchewan

Christopher Mpofu
Ph: 306-655-2914

Ireland

Co Dublin
Dublin

Our Lady's Hospital for Sick Children Crumlin

Gary E Campbell
Ph: (775) 823-1990

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

Switzerland

Geneva

Swiss Pediatric Oncology Group Geneva

Marc Ansari
Ph: 031 389 91 89

Lausanne

Swiss Pediatric Oncology Group Lausanne

Maja Beck Popovic
Ph: 31 389 91 89

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01190930
ClinicalTrials.gov processed this data on May 04, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.