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Clinical Trials (PDQ®)

Clinical Trials (PDQ®)

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

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

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, MDPrincipal Investigator

Peter Adamson, MDPh: 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: 205-934-0309
 UAB Comprehensive Cancer Center
 Alyssa T Reddy Ph: 205-934-0309
  Mobile
 University of South Alabama Mitchell Cancer Institute
 Felicia L Wilson Ph: 251-665-8000
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
 Brenda J Wittman 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
 Theresa M Harned Ph: 323-361-4110
 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: 562-933-5437
  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: 916-454-6500
  Email: cancerinfo@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
 Christopher N Frantz Ph: 302-651-5755
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
 Scott M Bradfield 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
 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
 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
 Glen Lew Ph: 404-785-1112
  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
 Cancer Research Center of Hawaii
 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 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
  Oak Lawn
 Keyser Family Cancer Center at Advocate Hope Children's Hospital
 Ammar Hayani Ph: 800-323-8622
  Park Ridge
 Advocate Lutheran General Cancer Care Center
 Jong-Hyo Kwon Ph: 847-384-3621
  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: 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
 Salvatore J Bertolone Ph: 866-530-5516
  Email: CancerResource@nortonhealthcare.org
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: 401-444-1488
  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
  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
 Katharina E Elliott 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
 Michael J Burke Ph: 414-805-4380
  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
 UNMC Eppley Cancer Center at the University of Nebraska Medical 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
 Nik Farahana N Rashid Ph: 702-384-0013
 Children's Specialty Center of 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
 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
 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
 Elizabeth A Raetz Ph: 801-585-5270
  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
 Claudio Sandoval Ph: 914-594-3794
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
  Email: cancerclinicaltrials@med.unc.edu
  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
  Greenville
 Leo W. Jenkins Cancer Center at ECU Medical School
 Mauro Grossi Ph: 252-744-2161
  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
  Email: info@siteman.wustl.edu
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
 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
 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
 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
 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: 901-595-4644
  Nashville
 Vanderbilt-Ingram Cancer Center
 Haydar A Frangoul Ph: 800-811-8480
Texas
  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
 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
  San Antonio
 Children's Hospital of San Antonio
 Timothy C Griffin Ph: 800-284-7370
 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
 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
  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: 888-823-5923
  Email: ctsucontact@westat.com
West Virginia
  Charleston
 West Virginia University Medical School - Charleston
 Howard M Grodman 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 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
 Royal Children's Hospital
 Helen Irving Ph: 888-823-5923
  Email: ctsucontact@westat.com
Victoria
  Clayton
 Monash Medical Center - Clayton Campus
 Peter A Downie
  Email: crdo.info@mcri.edu.au
  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 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
  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
  Ottawa
 Children's Hospital of Eastern Ontario
 Jacqueline M Halton Ph: 613-738-3931
  Toronto
 Hospital for Sick Children
 Ronald M Grant 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
 Michael L Capra Ph: 353 1 4096419
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

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01190930
ClinicalTrials.gov processed this data on September 16, 2014

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.