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Clinical Trials (PDQ®)

Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Monoclonal Antibody Ch14.18 in Treating Younger Patients With Refractory or Relapsed Neuroblastoma

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActiveChildrenNCINCI-2012-03125
COG-ANBL1221, CDR0000745188, ANBL1221, U10CA098543, U10CA180886, NCT01767194

Trial Description


This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide with temsirolimus or monoclonal antibody Ch14.18 work in treating younger patients with neuroblastoma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as monoclonal antibody Ch14.18, may find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving irinotecan hydrochloride and temozolomide together with temsirolimus or monoclonal antibody Ch14.18 is more effective in treating neuroblastoma.

Further Study Information


I. To identify whether temsirolimus or ch14.18 (monoclonal antibody Ch14.18) is the optimal therapeutic agent to consider for further testing in a future Phase III randomized trial for treatment of newly diagnosed high-risk neuroblastoma.


I. To compare the response rates (RR) for patients receiving temsirolimus or ch14.18 in combination with irinotecan (irinotecan hydrochloride) and temozolomide.

II. To compare the progression free survival (PFS) and overall survival (OS) rates for patients receiving temsirolimus or ch14.18 in combination with irinotecan and temozolomide.

III. To compare the toxicities associated with temsirolimus or ch14.18 when combined with irinotecan and temozolomide in patients with refractory, relapsed or progressive neuroblastoma.

IV. To compare the ability to maintain intended dose intensity of all agents when temsirolimus or ch14.18 is combined with irinotecan and temozolomide in patients with refractory, relapsed or progressive neuroblastoma.

V. To determine the concordance between tumor responses as defined by standard International Neuroblastoma Response Criteria (INRC) versus response per the revised INRC.

VI. To study the clinical relevance of naturally occurring anti-glycan antibodies in patients receiving ch14.18 antibody.

VII. To study the clinical relevance of natural killer (NK) receptor natural cytotoxicity triggering receptor 3 (NKp30) isoforms in patients receiving ch14.18 antibody or temsirolimus.

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

ARM I: Patients receive temozolomide orally (PO) on days 1-5, irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8.

ARM II: Patients receive temozolomide and irinotecan hydrochloride as in Arm I, monoclonal antibody Ch14.18 IV over 10-20 hours on days 2-5 and sargramostim subcutaneously (SC) or IV over 2 hours on days 6-12.

In both arms, treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

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

Eligibility Criteria

Inclusion Criteria:

  • Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines (i.e., > 2 x upper limit of normal [ULN]), at the time of initial diagnosis
  • For the purposes of this study, aggressive multidrug chemotherapy is defined as chemotherapy including 2 or more agents that must include an alkylating agent and a platinum-containing compound; patients must have ONE of the following:
  • First episode of recurrent disease following completion of aggressive multi-drug frontline therapy
  • First episode of progressive disease during aggressive multi-drug frontline therapy
  • Primary resistant/refractory disease detected at the conclusion of at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (examples include A3973, ANBL0532, ANBL09P1, etc.)
  • Patients must have at least ONE of the following:
  • Measurable tumor on magnetic resonance imaging (MRI), computed tomography (CT) scan obtained within 3 weeks prior to study entry; measurable is defined as >= 10 mm in at least one dimension on spiral/helical CT that is metaiodobenzylguanidine (MIBG) avid or demonstrates increased fludeoxyglucose (FDG) uptake on positron emission tomography (PET) scan
  • MIBG scan obtained within 3 weeks prior to study entry with positive uptake at a minimum of one site; this site must represent disease recurrence after completion of therapy, progressive disease on therapy, or refractory disease during induction
  • Patients with resistant/refractory soft tissue disease that is not MIBG avid or does not demonstrate increased FDG uptake on PET scan must undergo biopsy to document the presence of viable neuroblastoma; biopsy is not required for patients who have new site of soft tissue disease (radiographic evidence of disease progression) regardless of whether progression occurs while receiving therapy or after completion of therapy
  • Note: Patients with elevated catecholamines (i.e., > 2 x ULN) only or bone marrow disease only are NOT eligible for this study
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • Patients must have received frontline therapy (including surgery, chemotherapy, autologous stem cell transplant [SCT] +/- MIBG, immunotherapy, radiotherapy, and retinoids) but may NOT have received second line chemotherapy for resistant/refractory, relapsed disease or progressive disease
  • At least 14 days must have elapsed since completion of myelosuppressive therapy
  • At least 7 days must have elapsed since the completion of therapy with a non-myelosuppressive biologic agent or retinoid
  • No interim time prior to study entry is required following prior radiation therapy (RT) for non-target lesions; however, patients must not have received radiation for a minimum of 4 weeks prior to study entry at the site of any lesion that will be identified as a target lesion to measure tumor response; lesions that have been previously radiated cannot be used as target lesions unless there is radiographic evidence of progression at the site following radiation or a biopsy done following radiation shows viable neuroblastoma; palliative radiation is allowed to sites that will not be used to measure response during this study
  • Patients are eligible >= 6 weeks after autologous stem cell transplants or stem cell infusions as long as hematologic and other eligibility criteria have been met
  • Patients are eligible >= 6 weeks after therapeutic 131I-MIBG provided that all other eligibility criteria are met
  • Subjects who have previously received anti-disialoganglioside (GD2) monoclonal antibodies for biologic therapy or for tumor imaging are eligible unless they have had progressive disease while receiving prior anti-GD2 therapy; subjects who have received autologous marrow infusions or autologous stem cell infusions that were purged using monoclonal antibody linked to beads, but no other form of anti-GD2 monoclonal antibody, are eligible
  • Patients must not have received long-acting myeloid growth factors (e.g., Neulasta) within 14 days of entry on this study; seven days must have elapsed since administration of a short acting myeloid growth factor
  • Peripheral absolute neutrophil count (ANC) >= 750/uL
  • Platelet count >= 75,000/uL (transfusion independent)
  • Patients known to have bone marrow involvement with neuroblastoma are eligible provided that minimum ANC and platelet count criteria are met but are not evaluable for hematological toxicity
  • Creatinine clearance or estimated radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or
  • A serum creatinine =< upper limit of normal (ULN) based on age/gender as follows:
  • Age 1 month to < 6 months: 0.4 for males, 0.4 for females
  • Age 6 months to < 1 year: 0.5 for males, 0.5 for females
  • Age 1 to < 2 years: 0.6 for males, 0.6 for females
  • Age 2 to < 6 years: 0.8 for males, 0.8 for females
  • Age 6 to < 10 years: 1 for males, 1 for females
  • Age 10 to < 13 years: 1.2 for males, 1.2 for females
  • Age 13 to < 16 years: 1.5 for males, 1.4 for females
  • Age >= 16 years: 1.7 for males, 1.4 for females
  • Total bilirubin =< 1.5 x ULN for age AND
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5.0 x ULN for age (=< 225 U/L); for the purpose of this study, the ULN for SGPT is 45 U/L
  • Adequate central nervous system function defined as:
  • Patients with a history of central nervous system (CNS) disease must have no clinical or radiological evidence of CNS disease at the time of study enrollment
  • Patients with seizure disorders may be enrolled if seizures are well controlled on anticonvulsants
  • CNS toxicity =< grade 2
  • Shortening fraction of >= 27% by echocardiogram (ECHO) OR
  • Ejection fraction >= 50% by ECHO or gated radionuclide study
  • Adequate coagulation defined as:
  • Prothrombin time (PT) =< 1.2 x upper limit of normal
  • Serum lipids within acceptable range:
  • Serum triglyceride level =< 300 mg/dL and serum cholesterol level =< 300 mg/dL; If non-fasting values exceed these levels, lipid testing should be repeated in the fasting state
  • Adequate pulmonary function defined as:
  • No evidence of dyspnea at rest, no exercise intolerance, no chronic oxygen requirement, and room air pulse oximetry > 94% if there is a clinical indication for pulse oximetry; normal pulmonary function tests in patients who are capable of cooperating with testing (including diffusion capacity of the lung of carbon monoxide [DLCO]) are required if there is a clinical indication for determination; for patients who do not have respiratory symptoms, full pulmonary function tests (PFTs) are NOT required

Exclusion Criteria:

  • Men and women of childbearing potential and their partners must agree to use adequate contraception while enrolled on this study; based on the established teratogenic potential of alkylating agents and temsirolimus, pregnant women will be excluded from this study; because of potential risks to breastfed infants due to drug metabolites that could be excreted in breast milk, female patients who are lactating must agree to stop breastfeeding or will otherwise be excluded from this study; females of childbearing potential must have a negative pregnancy test to be eligible for this study
  • Patients with elevated catecholamines (i.e., > 2 x ULN) only or bone marrow disease only are NOT eligible for this study
  • Patients must have been off pharmacologic doses of systemic steroids for at least 7 days prior to enrollment; patients who require or are likely to require pharmacologic doses of systemic corticosteroids while receiving treatment on this study are ineligible; the only exception is for patients known to require 2 mg/kg or less of hydrocortisone (or an equivalent dose of an alternative corticosteroid) as premedication for blood product administration in order to avoid allergic transfusion reactions; the use of conventional doses of inhaled steroids for the treatment of asthma is permitted, as is the use of physiologic doses of steroids for patients with known adrenal insufficiency
  • Patients must not have received enzyme-inducing anticonvulsants including phenytoin, phenobarbital, valproic acid, or carbamazepine for at least 7 days prior to study enrollment; patients receiving non-enzyme inducing anticonvulsants such as gabapentin or levetiracetam will be eligible
  • Patients must not have been diagnosed with myelodysplastic syndrome or with any malignancy other than neuroblastoma
  • Patients with symptoms of congestive heart failure are not eligible
  • Patients must not have >= grade 2 diarrhea
  • Patients must not have uncontrolled infection
  • Patients who have received prior therapy with an mammalian target of rapamycin (mTOR) inhibitor in combination with cytotoxic chemotherapy are not eligible
  • Patients with a history of significant allergic reactions attributed to compounds of similar chemical or biologic composition to temsirolimus are not eligible
  • Patients with a history of grade 4 allergic reactions to anti-GD2 antibodies or reactions that required discontinuation of the anti-GD2 therapy are not eligible
  • Patients with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of study agents or to significantly increase the severity of the toxicities experienced from study treatment are not eligible

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Rajen ModyPrincipal Investigator

Trial Sites

 Phoenix Children's Hospital
 Jessica Boklan Ph: 602-546-0920
 Southern California Permanente Medical Group
 Robert M Cooper Ph: 626-564-3455
  Loma Linda
 Loma Linda University Cancer Institute at Loma Linda University Medical Center
 Antranik A Bedros Ph: 909-558-3375
  Los Angeles
 Children's Hospital Los Angeles
 Leo Mascarenhas Ph: 323-361-4110
 Children's Hospital Central California
 Vonda L Crouse Ph: 866-353-5437
 Kaiser Permanente-Oakland
 Steven K Bergstrom Ph: 626-564-3455
 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
 University of California Davis Cancer Center
 Jay Michael S Balagtas Ph: 916-734-3089
  San Diego
 Rady Children's Hospital - San Diego
 William D Roberts Ph: 858-966-5934
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Katherine K Matthay Ph: 877-827-3222
 Presbyterian - St. Luke's Medical Center
 Jennifer J Clark Ph: 866-775-6246
 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
 Alfred I. duPont Hospital for Children
 Ramamoorthy Nagasubramanian Ph: 407-650-7150
District of Columbia
 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
  Fort Myers
 Children's Hospital of Southwest Florida
 Emad K Salman Ph: 239-343-5333
 UF Health Cancer Center
 William B Slayton Ph: 352-273-8675
 Nemours Children's Clinic
 Ramamoorthy Nagasubramanian Ph: 407-650-7150
 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
 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
 Nemours Children's Clinic - Pensacola
 Ramamoorthy Nagasubramanian Ph: 407-650-7150
  Saint Petersburg
 All Children's Hospital
 Gregory A Hale Ph: 727-767-2423
 St. Joseph's Children's Hospital of Tampa
 Dana A Obzut Ph: 800-882-4123
 AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
 Glen Lew Ph: 404-785-1112
 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
 J. M Johnston Ph: 912-350-8568
 Kapiolani Medical Center for Women and Children
 Robert W Wilkinson Ph: 808-983-6090
 Ann and Robert H. Lurie Children's Hospital of Chicago
 Yasmin C Gosiengfiao 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
  Oak Lawn
 Keyser Family Cancer Center at Advocate Hope Children's Hospital
 Rebecca E McFall Ph: 847-723-7570
 Saint Jude Midwest Affiliate
 Karen S Fernandez Ph: 309-655-3258
 Simmons Cooper Cancer Institute
 Gregory P Brandt Ph: 217-545-7929
 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
  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
 University of Kentucky Chandler Medical Center
 Lars M Wagner Ph: 859-257-3379
 Kosair Children's Hospital
 Kenneth G Lucas Ph: 866-530-5516
  New Orleans
 Children's Hospital of New Orleans
 Lolie C Yu Ph: 504-894-5377
 CancerCare of Maine at Eastern Maine Medical Center
 Sam W Lew Ph: 207-973-4274
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Joseph M Wiley Ph: 410-601-6120
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Allen R. Chen Ph: 410-955-8804
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Carlos Rodriguez-Galindo Ph: 866-790-4500
  Ann Arbor
 C.S. Mott Children's Hospital at University of Michigan Medical Center
 Rajen Mody Ph: 800-865-1125
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Hadi Sawaf Ph: 313-343-3166
 Wayne State University
 Zhihong J Wang Ph: 313-576-9363
  East Lansing
 Breslin Cancer Center at Ingham Regional Medical Center
 Renuka Gera Ph: 517-975-9547
  Grand Rapids
 Helen DeVos Children's Hospital at Spectrum Health
 David S Dickens Ph: 616-267-1925
 Children's Hospitals and Clinics of Minnesota - Minneapolis
 Bruce C Bostrom Ph: 612-813-5193
 Masonic Cancer Center at University of Minnesota
 Emily G Greengard Ph: 612-624-2620
 Mayo Clinic Cancer Center
 Carola A. S. Arndt Ph: 507-538-7623
 University of Mississippi Cancer Clinic
 Gail C Megason Ph: 601-815-6700
  Kansas City
 Children's Mercy Hospital
 Maxine L Hetherington Ph: 816-234-3265
  Saint Louis
 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
 Children's Hospital
 Minnie Abromowitch Ph: 402-955-3949
 Fred and Pamela Buffett Cancer Center
 Minnie Abromowitch Ph: 402-955-3949
  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
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Sara Chaffee Ph: 800-639-6918
New Jersey
 Hackensack University Medical Center Cancer Center
 Burton E Appel Ph: 201-996-2879
 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
New Mexico
 University of New Mexico Cancer Center
 Koh B Boayue Ph: 505-272-6972
New York
 Albany Medical Center Hospital
 Vikramjit S Kanwar Ph: 518-262-3368
 Montefiore Medical Center
 Peter D Cole Ph: 718-904-2730
 Winthrop University Hospital
 Mark E Weinblatt Ph: 866-946-8476
  New Hyde Park
 Schneider Children's Hospital
 Jonathan D Fish Ph: 718-470-3470
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Alice Lee Ph: 212-305-8615
 SUNY Upstate Medical University Hospital
 Karol H Kerr Ph: 315-464-5476
 New York Medical College
 Jessica C Hochberg Ph: 914-594-3794
North Carolina
 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
 Blumenthal Cancer Center at Carolinas Medical Center
 Joel A Kaplan Ph: 704-355-2884
 Duke Cancer Institute
 Susan G Kreissman Ph: 888-275-3853
 Akron Children's Hospital
 Steven J Kuerbitz Ph: 330-543-3193
 Cincinnati Children's Hospital Medical Center
 John P Perentesis Ph: 513-636-2799
 Seidman Cancer Center at University Hospitals/Case Medical Center
 Yousif (Joe) H Matloub Ph: 216-844-5437
 Nationwide Children's Hospital
 Mark A Ranalli Ph: 614-722-2708
 Dayton Children's - Dayton
 Emmett H Broxson Ph: 800-228-4055
 Toledo Hospital
 Jamie L Dargart Ph: 419-824-1842
  Oklahoma City
 Stephenson Cancer Center at the University of Oklahoma
 Rene Y McNall-Knapp Ph: 405-271-4272
 Knight Cancer Institute at Oregon Health and Science University
 Susan J Lindemulder Ph: 503-494-1080
 Legacy Emanuel Children's Hospital
 Janice F Olson Ph: 503-413-2560
 Children's Hospital of Philadelphia
 Rochelle Bagatell Ph: 215-590-2810
 St. Christopher's Hospital for Children
 Akash Nahar Ph: 215-427-8991
 Children's Hospital of Pittsburgh of UPMC
 Jean M Tersak Ph: 412-692-5573
  San Juan
 San Jorge Children's Hospital
 Luis A Clavell Ph: 888-823-5923
South Carolina
 Palmetto Health South Carolina Cancer Center
 Ronnie W. Neuberg Ph: 803-434-3680
 BI-LO Charities Children's Cancer Center
 Nichole L Bryant Ph: 864-241-6251
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Kayelyn J Wagner Ph: 605-328-1367
 East Tennessee Children's Hospital
 Ray C Pais Ph: 865-541-8266
 Vanderbilt-Ingram Cancer Center
 Howard M Katzenstein Ph: 800-811-8480
 Dell Children's Medical Center of Central Texas
 Sharon K Lockhart Ph: 512-324-8022
 Medical City Dallas Hospital
 Carl Lenarsky Ph: 972-566-5588
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Tanya C Watt Ph: 214-648-7097
  Fort Worth
 Cook Children's Medical Center - Fort Worth
 Mary Meaghan P Granger Ph: 682-885-2103
 Covenant Children's Hospital
 Latha Prasannan Ph: 806-725-8000
  Salt Lake City
 Primary Children's Medical Center
 Phillip E Barnette Ph: 801-585-5270
 University of Virginia Cancer Center
 William C Petersen Ph: 434-243-6143
 Children's Hospital of The King's Daughters
 Eric J Lowe Ph: 757-668-7243
 Virginia Commonwealth University Massey Cancer Center
 Gita V Massey Ph: 804-628-1939
 Children's Hospital and Regional Medical Center - Seattle
 Douglas S Hawkins Ph: 866-987-2000
 Providence Cancer Center at Sacred Heart Medical Center
 Judy L Felgenhauer Ph: 800-228-6618
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Kenneth B DeSantes Ph: 608-262-5223
 Marshfield Clinic - Marshfield Center
 Michael J McManus Ph: 715-389-4457
New South Wales
 Children's Hospital at Westmead
 Geoffrey B McCowage Ph: 61-2-9845 1400
  South Brisbane
 Lady Cilento Children's Hospital
 Helen Irving Ph: 888-823-5923
Western Australia
 Princess Margaret Hospital for Children
 Catherine H Cole Ph: (08) 9340 8222
 Alberta Children's Hospital
 Douglas R Strother Ph: 403-220-6898
 University of Alberta Hospital
 Sunil Jayantilal S Desai Ph: 780-407-6615
British Columbia
 Children's and Women's Hospital of British Columbia
 Caron Strahlendorf Ph: 604-875-2345ext6477
 CancerCare Manitoba
 Rochelle A Yanofsky Ph: 866-561-1026
Newfoundland and Labrador
  Saint John's
 Janeway Children's Health and Rehabilitation Centre
 Lisa Anne B Goodyear Ph: 866-722-1126
Nova Scotia
 IWK Health Centre
 Conrad V Fernandez Ph: 902-470-8394
 McMaster Children's Hospital at Hamilton Health Sciences
 Carol Portwine Ph: 905-521-2100ext74595
 Children's Hospital of Eastern Ontario
 Jacqueline M Halton Ph: 613-738-3931
 Hospital for Sick Children
 Meredith S Irwin Ph: 416-813-7654ext2027
 Hopital Sainte Justine
 Yvan Samson Ph: 514-345-4931
 Montreal Children's Hospital at McGill University Health Center
 Sharon B Abish Ph: 514-412-4445
 Centre de Recherche du Centre Hospitalier de l'Universite Laval
 Bruno Michon Ph: 418-525-4444

Link to the current record.
NLM Identifer NCT01767194 processed this data on March 17, 2015

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

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