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Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActiveUnder 3NCI, OtherACNS0334
NCI-2009-00338, COG-ACNS0334, CDR0000483683, U10CA098543, NCT00336024

Trial Description

Summary

This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given before a peripheral stem cell transplant in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with a peripheral stem cell transplant may allow more chemotherapy to be given so that more tumor cells are killed. It is not yet known which combination chemotherapy regimen is more effective when given before a peripheral stem cell transplant in treating supratentorial primitive neuroectodermal tumors or medulloblastoma.

Further Study Information

PRIMARY OBJECTIVES:

I. Determine if treatment of pediatric patients with newly diagnosed supratentorial primitive neuroectodermal CNS tumors or high-risk medulloblastoma with intensive induction chemotherapy comprising vincristine, etoposide, cyclophosphamide, and cisplatin in combination with high-dose methotrexate and leucovorin calcium followed by consolidation chemotherapy comprising carboplatin and thiotepa and peripheral blood stem cell rescue results in a higher complete response rate then in patients treated with the same regimen without high-dose methotrexate and leucovorin calcium.

SECONDARY OBJECTIVES:

I. Determine whether biologic characterization of these tumors will refine therapeutic stratification separating atypical teratoid rhabdoid tumors from primitive neuroectodermal tumors (PNETs) and possibly identifying other markers of value for stratification within the group of PNETs.

II. Compare event-free survival and patterns of failure in patients treated with these regimens.

III. Compare the acute, chronic, and late effects of these regimens, particularly in terms of tolerance to the same consolidation regimen after treatment with 2 different induction regimens, in these patients.

IV. Compare the gastrointestinal and nutritional toxicities of these regimens in these patients.

V. Compare the quality of life outcomes in patients treated with these regimens.

VI. Compare the neuropsychological effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to diagnosis* (M0 medulloblastoma with ≥ 1.5 cm² residual tumor vs M1 medulloblastoma [positive lumbar CSF cytology] vs M2, M3, or M4 medulloblastoma vs supratentorial PNET [any M-stage] vs M0 medulloblastoma < 8 months without residual disease or with < 1.5 cm² radiographic measurable residual tumor vs anaplastic M0 medulloblastoma without residual disease or with < 1.5 cm² radiographic measurable residual vs classic M0 (nondesmoplastic) medulloblastoma with < 1.5 cm² radiographic measurable residual tumor).

NOTE: *All diagnoses are for children < 36 months unless otherwise noted.

INDUCTION THERAPY: Patients are randomized to 1 of 2 induction treatment arms.

ARM I: Patients receive vincristine IV on days 1, 8, and 15; etoposide IV over 1 hour on days 1-3; cyclophosphamide IV over 1 hour on days 1 and 2; cisplatin IV over 6 hours on day 3; and filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive vincristine IV on days 1, 8, and 15; high-dose methotrexate IV over 4 hours on day 1; and leucovorin calcium IV or orally every 6 hours beginning on day 2 and continuing until methotrexate levels are in a safe range. Once methotrexate levels are in a safe range, patients then receive etoposide IV over 1 hour on approximately days 4, 5, and 6, cyclophosphamide IV over 1 hour on approximately days 4 and 5, and cisplatin IV over 6 hours on approximately day 6. Patients also receive G-CSF IV or SC beginning 24 hours after the completion of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

In both arms, patients with stable disease or partial response after induction therapy proceed to second-look surgery followed by consolidation therapy. Patients with a complete response after induction therapy proceed directly to consolidation therapy.

CONSOLIDATION THERAPY: Beginning no more than 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and G-CSF IV or SC beginning on day 54 and continuing until blood counts recover. Patients also receive autologous peripheral blood stem cells (PBSC) IV on day 4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples are collected at baseline for correlative studies, including gene expression profiling, biological marker analysis (i.e., cMyc, ErbB2/ErbB4), comparative genome analysis, and mutation analysis.

After completion of study therapy, patients are followed up periodically for 4 years and then annually thereafter.

Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of 1 of the following:
  • High-risk medulloblastoma defined by any of the following:
  • Residual disease > 1.5 cm²
  • Lumbar cerebral spinal fluid cytology positive for tumor cells by analysis of fluid collected either before definitive surgery or ≥ 10 days after definitive surgery unless contraindicated
  • M0 disease in children < 8 months of age at diagnosis
  • M2 or M3 metastatic disease by MRI
  • M4 disease
  • Supratentorial primitive neuroectodermal tumor (PNET)(any M-stage)
  • Anaplastic medulloblastoma regardless of M-stage or residual tumor
  • M0 classic, non-desmoplastic medulloblastoma (R1) with radiographically measurable residual disease < 1.5 cm^2
  • MRI evidence of spinal disease
  • Tumor must be negative for INI1 gene
  • Has undergone definitive surgery within the past 31 days
  • No atypical teratoid rhabdoid tumors
  • Biological specimens must be available for correlative laboratory studies
  • Life expectancy > 8 weeks
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 60 mL/min
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT < 2 times ULN
  • Shortening fraction ≥ 27% by echocardiogram
  • Ejection fraction ≥ 47% by radionuclide angiogram
  • No evidence of dyspnea at rest
  • Pulse oximetry > 94% on room air
  • Absolute neutrophil count > 1,000/mm³
  • Platelet count > 100,000/mm³ (transfusion independent)
  • Hemoglobin > 8 g/dL (RBC transfusions allowed)
  • Prior corticosteroids allowed
  • No prior radiation therapy or chemotherapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

National Cancer Institute

Claire MazewskiPrincipal Investigator

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
Arizona
  Phoenix
 Phoenix Children's Hospital
 Jessica Boklan Ph: 602-546-0920
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
  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
 Amanda M Termuhlen Ph: 562-933-5437
  Los Angeles
 Children's Hospital Los Angeles
 Leo Mascarenhas Ph: 323-361-4110
 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
  Orange
 Children's Hospital of Orange County
 Violet Shen Ph: 714-997-3000
  Sacramento
 University of California Davis Cancer Center
 Jay Michael S Balagtas Ph: 916-734-3089
  San Diego
 Rady Children's Hospital - San Diego
 William D Roberts Ph: 858-966-5934
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Anuradha Banerjee Ph: 877-827-3222
Colorado
  Aurora
 Children's Hospital Colorado Center for Cancer and Blood Disorders
 Nicholas K Foreman Ph: 720-777-6672
Connecticut
  Hartford
 Connecticut Children's Medical Center
 Michael S Isakoff Ph: 860-545-9981
Delaware
  Wilmington
 Alfred I. duPont Hospital for Children
 Christopher N Frantz Ph: 302-651-5755
District of Columbia
  Washington
 Children's National Medical Center
 Jeffrey S Dome Ph: 202-884-2549
Florida
  Fort 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
 Eric S Sandler Ph: 904-697-3529
  Miami
 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
 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
  West Palm Beach
 Kaplan Cancer Center at St. Mary's Medical Center
 Narayana Gowda Ph: 888-823-5923
  Email: ctsucontact@westat.com
Georgia
  Atlanta
 AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
 Howard M Katzenstein Ph: 800-811-8480
  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
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
 Stewart Goldman Ph: 773-880-4562
  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
Indiana
  Indianapolis
 St. Vincent Indianapolis Hospital
 Bassem I Razzouk Ph: 317-338-2194
Iowa
  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
 Martha F Greenwood Ph: 859-257-3379
  Louisville
 Kosair Children's Hospital
 Salvatore J Bertolone Ph: 866-530-5516
Louisiana
  New Orleans
 Tulane Cancer Center at Tulane University Hospital and Clinic
 Tammuella C Singleton Ph: 504-988-6121
Maine
  Bangor
 CancerCare of Maine at Eastern Maine Medical Center
 Sarah J Fryberger Ph: 207-973-4274
Maryland
  Baltimore
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Kenneth J Cohen Ph: 410-955-8804
  Email: jhcccro@jhmi.edu
  Bethesda
 National Naval Medical Center
 Anne B Warwick Ph: 301-319-2100
Massachusetts
  Boston
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Carlos Rodriguez-Galindo Ph: 866-790-4500
 Floating Hospital for Children at Tufts - New England Medical Center
 Michael J Kelly Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
Michigan
  Ann Arbor
 C.S. Mott Children's Hospital at University of Michigan Medical Center
 Patricia L Robertson Ph: 800-865-1125
  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
Minnesota
  Minneapolis
 Children's Hospitals and Clinics of Minnesota - Minneapolis
 Bruce C Bostrom Ph: 612-813-5193
 Masonic Cancer Center at University of Minnesota
 Christopher L Moertel Ph: 612-624-2620
  Rochester
 Mayo Clinic Cancer Center
 Carola A. S. Arndt Ph: 507-538-7623
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Gail C Megason Ph: 601-815-6700
Missouri
  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
 Shalini Shenoy Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 Nik Farahana N Rashid Ph: 702-384-0013
New Jersey
  Hackensack
 Hackensack University Medical Center Cancer Center
 Stephen J Thompson 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
  Newark
 Newark Beth Israel Medical Center
 Peri Kamalakar Ph: 973-926-7230
  Paterson
 St. Joseph's Hospital and Medical Center
 Mary A Bonilla Ph: 973-754-2909
  Summit
 Overlook Hospital
 Steven L Halpern Ph: 973-971-5900
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Koh B Boayue Ph: 505-272-6972
New York
  Bronx
 Montefiore Medical Center
 Rosanna J Ricafort Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
  Buffalo
 Roswell Park Cancer Institute
 Martin L Brecher Ph: 877-275-7724
  Mineola
 Winthrop University Hospital
 Mark E Weinblatt Ph: 866-946-8476
  New York
 Memorial Sloan-Kettering Cancer Center
 Peter G Steinherz Ph: 212-639-7202
 New York University Medical Center
 Jeffrey C Allen Ph: 212-263-4434
  Email: prmc.coordinator@nyumc.org
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jeffrey R Andolina Ph: 585-275-5830
  Stony Brook
 Stony Brook University Cancer Center
 Robert I Parker Ph: 800-862-2215
  Valhalla
 New York Medical College
 Mehmet F Ozkaynak Ph: 914-594-3794
North Carolina
  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
North Dakota
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Nathan L Kobrinsky Ph: 701-234-6161
Ohio
  Cincinnati
 Cincinnati Children's Hospital Medical Center
 John P Perentesis Ph: 513-636-2799
  Cleveland
 Cleveland Clinic Taussig Cancer Center
 Tanya M Tekautz Ph: 866-223-8100
  Columbus
 Nationwide Children's Hospital
 Mark A Ranalli Ph: 614-722-2708
  Dayton
 Dayton Children's - Dayton
 Emmett H Broxson Ph: 800-228-4055
  Toledo
 Mercy Children's Hospital
 Rama Jasty Ph: 419-251-8210
 Toledo Hospital
 Dagmar T Stein Ph: 419-824-1842
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Rene Y McNall-Knapp Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Portland
 Knight Cancer Institute at Oregon Health and Science University
 Kellie J Nazemi Ph: 503-494-1080
  Email: trials@ohsu.edu
 Legacy Emanuel Children's Hospital
 Janice F Olson Ph: 503-413-2560
 Legacy Emanuel Hospital and Health Center and Children's Hospital
 Janice F Olson Ph: 503-413-2560
Pennsylvania
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Jeffrey S Taylor Ph: 570-271-5251
  Philadelphia
 Children's Hospital of Philadelphia
 Michael J Fisher Ph: 215-590-2810
 St. Christopher's Hospital for Children
 Gregory E Halligan Ph: 215-427-8991
  Pittsburgh
 Children's Hospital of Pittsburgh of UPMC
 Regina I Jakacki Ph: 412-692-5573
PR
  Santurce
 San Jorge Children's Hospital
 Luis A Clavell Ph: 888-823-5923
  Email: ctsucontact@westat.com
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
 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
Tennessee
  Knoxville
 East Tennessee Children's Hospital
 Ray C Pais Ph: 865-541-8266
  Nashville
 Vanderbilt-Ingram Cancer Center
 Haydar A Frangoul Ph: 800-811-8480
Texas
  Corpus Christi
 Driscoll Children's Hospital
 M. C Johnson Ph: 361-694-5311
  Dallas
 Medical City Dallas Hospital
 Carl Lenarsky Ph: 972-566-5588
  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
 Murali M Chintagumpala Ph: 713-798-1354
  Email: burton@bcm.edu
  San Antonio
 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: 210-567-0653
  Email: che@uthscsa.edu
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
  Falls Church
 Inova Fairfax Hospital
 Marshall A Schorin Ph: 703-208-6650
  Portsmouth
 Naval Medical Center - Portsmouth
 Bethany M Mikles Ph: 757-953-5939
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Asadullah Khan Ph: 804-628-1939
Washington
  Seattle
 Children's Hospital and Regional Medical Center - Seattle
 Jeffrey R Geyer Ph: 866-987-2000
  Spokane
 Providence Cancer Center at Sacred Heart Medical Center
 Judy L Felgenhauer Ph: 800-228-6618
  Email: HopeBeginsHere@providence.org
  Tacoma
 Mary Bridge Children's Hospital and Health Center - Tacoma
 Robert G Irwin Ph: 888-823-5923
  Email: ctsucontact@westat.com
Wisconsin
  Marshfield
 Marshfield Clinic - Marshfield Center
 Michael J McManus Ph: 715-389-4457
  Milwaukee
 Midwest Children's Cancer Center at Children's Hospital of Wisconsin
 Sachin S Jogal Ph: 414-805-4380
Australia
New South Wales
  Randwick
 Sydney Children's Hospital
 Geoffrey B McCowage Ph: 61-2-9845 1400
  Westmead
 Children's Hospital at Westmead
 Geoffrey B McCowage Ph: 61-2-9845 1400
Victoria
  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
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
Nova Scotia
  Halifax
 IWK Health Centre
 Margaret C Yhap Ph: 902-470-8394
Ontario
  Hamilton
 McMaster Children's Hospital at Hamilton Health Sciences
 Carol Portwine Ph: 905-521-2100ext74595
 Carol Portwine Ph: 905-521-2100ext74595
  Kingston
 Cancer Centre of Southeastern Ontario at Kingston General Hospital
 Mariana P Silva Ph: 613-544-2630
  Ottawa
 Children's Hospital of Eastern Ontario
 Jacqueline M Halton Ph: 613-738-3931
  Toronto
 Hospital for Sick Children
 Sarah W Alexander Ph: 416-813-7654ext2027
  Email: jason.mcguire@sickkids.ca
Quebec
  Montreal
 Hopital Sainte Justine
 Yvan Samson Ph: 514-345-4931
 Montreal Children's Hospital at McGill University Health Center
 Sharon B Abish Ph: 514-412-4445
  Email: info@thechildren.com
  Ste-Foy
 Centre de Recherche du Centre Hospitalier de l'Universite Laval
 Bruno Michon Ph: 418-525-4444

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00336024
ClinicalTrials.gov processed this data on February 05, 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.

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