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Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma - Article


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Sargramostim Injection

GM-CSF; Leukine; Prokine



Clinical Trial: Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma

This study is currently recruiting patients.

Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Inhaling aerosolized sargramostim before and after surgery may interfere with the growth of tumor cells and shrink the tumor so that it can be removed during surgery. Sargramostim may then kill any tumor cells remaining after surgery. This may be an effective treatment for osteosarcoma that has spread to the lung.

PURPOSE: Phase II trial to study the effectiveness of inhaled sargramostim in treating patients who are undergoing surgery for the first recurrence of osteosarcoma that has spread to the lung.

Condition Treatment or Intervention Phase
metastatic osteosarcoma
recurrent osteosarcoma
lung metastases
 Drug: sargramostim
 Procedure: adjuvant therapy
 Procedure: biological response modifier therapy
 Procedure: colony-stimulating factor therapy
 Procedure: conventional surgery
 Procedure: cytokine therapy
 Procedure: neoadjuvant therapy
 Procedure: non-specific immune-modulator therapy
 Procedure: surgery
Phase II

MedlinePlus related topics:  Bone Cancer;   Lung Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Aerosolized Sargramostim (GM-CSF) in Patients With First Pulmonary Recurrence of Osteosarcoma

Further Study Details: 

OBJECTIVES:

  • Assess the histological findings from patients with first pulmonary recurrence of osteosarcoma who undergo resection of pulmonary metastases after treatment with 2 courses of aerosolized sargramostim (GM-CSF).
  • Determine the event-free survival of patients treated with this drug.
  • Determine the effect of specific thoracic surgical management on outcome in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to the extent of pulmonary recurrence (unilateral or bilateral).

  • Initial inhalation therapy: Patients receive inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every 14 days for 2 courses.
  • Thoracotomy: Patients undergo thoracotomy on day 22.
  • Post-thoracotomy inhalation therapy: Beginning on day 29, patients resume inhalation therapy as above for up to 12 additional courses.
  • Unilateral thoracotomy: Patients undergo unilateral thoracotomy on day 1.
  • Initial inhalation therapy: Patients receive inhaled GM-CSF twice daily on days 7-14. Treatment repeats every 14 days for 2 courses.
  • Contralateral thoracotomy: Patients undergo contralateral thoracotomy on day 29.
  • Post-thoracotomy inhalation therapy: Beginning on day 36, patients resume inhalation therapy as above for up to 12 additional courses. Treatment in both groups continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1.6-2 years.

Eligibility

Ages Eligible for Study:  up to  39 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed osteosarcoma at primary diagnosis
  • Lesions detected in at least 1 lung that are consistent with metastatic disease and approachable with thoracotomy
  • No prior recurrence of osteosarcoma
  • No other sites of metastases
  • Resectable pulmonary nodule(s), defined as nodule(s) that are removable without performing a pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels)
  • Prior thoracotomy allowed in patients with imaging consistent with metastatic involvement in both lungs provided the lung on which the thoracotomy was performed is disease-free
  • No pleural effusion

PATIENT CHARACTERISTICS: Age

  • 39 and under

Performance status

  • Karnofsky 50-100% (patients over 16 years of age)
  • Lansky 50-100% (patients 16 years of age and under)

Life expectancy

  • At least 8 weeks

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Pulmonary

  • No evidence of dyspnea at rest
  • No exercise intolerance
  • Pulse oximetry at least 94%
  • Baseline FEV_1 at least 75% of normal

Other

  • Willing and able to perform inhalation therapy
  • No medical contraindication to surgical excision

PRIOR CONCURRENT THERAPY: Biologic therapy

  • No other concurrent immunotherapy
  • No other concurrent immunomodulating agents

Chemotherapy

  • No concurrent anticancer chemotherapy

Endocrine therapy

  • No concurrent steroids by any route

Radiotherapy

  • Not specified

Surgery

Other

  • No more than 1 prior treatment regimen for osteosarcoma
  • No concurrent participation in another COG therapeutic study

Location and Contact Information


Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35233,  United States; Recruiting
Robert P. Castleberry, MD  205-939-9285    rcastleberry@peds.uab.edu 

      University of South Alabama Cancer Research Institute, Mobile,  Alabama,  36604,  United States; Recruiting
Felicia L. Wilson, MD  251-405-5115    fwilson@usouthal.edu 

Arizona
      Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson,  Arizona,  85724,  United States; Recruiting
Rochelle Bagatell, MD  520-626-4851 

      Phoenix Children's Hospital, Phoenix,  Arizona,  85016,  United States; Recruiting
Jessica Boklan, MD  602-546-0920 

Arkansas
      Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States; Recruiting
David L. Becton, MD  501-320-5650 

California
      Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange,  California,  92868,  United States; Recruiting
Stanley Calderwood, MD  714-456-6615    scalderw@uci.edu 

      Children's Hospital and Health Center, San Diego, San Diego,  California,  92123-4282,  United States; Recruiting
Richard Kadota, MD  858-966-5811 

      Children's Hospital and Research Center at Oakland, Oakland,  California,  94609-1809,  United States; Recruiting
James H. Feusner, MD  510-428-3000    jfeusner@mail.cho.org 

      Children's Hospital Central California, Madera,  California,  93638-8762,  United States; Recruiting
Vonda Lee Crouse, MD  559-353-5480    vcrouse@childrenscentralcal.org 

      Children's Hospital Los Angeles, Los Angeles,  California,  90027-0700,  United States; Recruiting
Paul S. Gaynon, MD  323-669-2163    pgaynon@chla.usc.edu 

      Children's Hospital of Orange County, Orange,  California,  92868,  United States; Recruiting
Wei-Ping Violet Shen, MD  714-516-4348    vshen@choc.org 

      General Robert Huyser Cancer Center at David Grant Medical Center, Travis Air Force Base,  California,  94535,  United States; Recruiting
Peter J. Chenaille, MD  707-423-7176 

      Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach,  California,  90801-1428,  United States; Recruiting
William Mark Roberts, MD  562-933-8600    wmroberts@memorialcare.org 

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States; Recruiting
Stephen A. Feig, MD  310-825-5268 

      Kaiser Permanente Medical Center - Sacramento, Sacramento,  California,  95825,  United States; Recruiting
Vincent A. Kiley, MD  916-973-7331    vincent.kiley@kp.org 

      Kaiser Permanente Medical Center - Santa Clara, Santa Clara,  California,  95051-5386,  United States; Recruiting
Carolyn Lucille Russo, MD  408-236-5028    carolyn.l.russo@kp.org 

      Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego, San Diego,  California,  92120,  United States; Recruiting
Wellington Loh, MD  619-516-6144 

      Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States; Recruiting
Antranik Bedros, MD  909-558-8626    abedro@ahs.llumc.edu 

      Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto,  California,  94304,  United States; Recruiting
Neyssa M. Marina, MD  650-723-5535    neyssa.marina@stanford.edu 

      Rebecca and John Moores UCSD Cancer Center, La Jolla,  California,  92093-0658,  United States; Recruiting
Richard Kadota, MD  858-657-7020 

      Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States; Recruiting
Moshe Arditi, MD  310-423-4471 

      Santa Barbara Cottage Hospital, Santa Barbara,  California,  93102,  United States; Recruiting
Felicity Hodder, MD  805-682-7111    fhodder@cottagehealthsystem.org 

      Southern California Permanente Medical Group, Downey,  California,  90242,  United States; Recruiting
Willye B. Powell, MD  562-803-2472 

      Sutter Cancer Center, Sacramento,  California,  95816,  United States; Recruiting
Yisheng Lee, MD, PhD, MBA  916-733-1757 

      UCSF Comprehensive Cancer Center, San Francisco,  California,  94143,  United States; Recruiting
Katherine K. Matthay, MD  415-476-3831 

Colorado
      Children's Hospital Cancer Center, Denver,  Colorado,  80218,  United States; Recruiting
Roger Howard Giller, MD  303-861-6892    giller.roger@tchden.org 

      Presbyterian - St. Luke's Medical Center, Denver,  Colorado,  80218,  United States; Recruiting
Stephen R. Palmer, MD  719-471-2462 

Connecticut
      Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington,  Connecticut,  06360-7106,  United States; Recruiting
Arnold J. Altman, MD  860-545-9630 

      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520-8064,  United States; Recruiting
Jack van Hoff, MD  203-785-4640    jack.vanhoff@yale.edu 

Delaware
      Alfred I. duPont Hospital for Children, Wilmington,  Delaware,  19899,  United States; Recruiting
Rita S. Meek, MD  302-651-5502    rmeek@nemours.org 

District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  20010-2970,  United States; Recruiting
Nita Louise Seibel, MD  202-884-2144    nseibel@cnmc.org 

      Lombardi Cancer Center at Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States; Recruiting
Aziza Shad, MD  202-444-2224    shada@georgetown.edu 

Florida
      All Children's Hospital, St. Petersburg,  Florida,  33701,  United States; Recruiting
Jerry L. Barbosa, MD  727-892-4231    barbosaj@allkids.org 

      Baptist-South Miami Regional Cancer Program, Miami,  Florida,  33176-2197,  United States; Recruiting
Doured Daghistani, MD  786-596-1960 

      Broward General Medical Center, Fort Lauderdale,  Florida,  33316,  United States; Recruiting
Rudolph R. Roskos, MD  954-355-4527    rroskos@nbhd.org 

      Children's Hospital of Southwest Florida, Fort Myers,  Florida,  33908,  United States; Recruiting
Emad K. Salman, MD  239-432-3333    emad.salman@leememorial.org 

      Florida Hospital Cancer Institute, Orlando,  Florida,  32804,  United States; Recruiting
Jane Crofton, RN, BSN, OCN  407-303-2090 

      Jackson Memorial Hospital, Miami,  Florida,  33136,  United States; Recruiting
Stuart R. Toledano, MD  305-585-5635    stoledan@med.miami.edu 

      Joe DiMaggio Children's Hospital at Memorial, Hollywood,  Florida,  33021,  United States; Recruiting
Iftikhar Hanif, MD  954-986-2234    ifhanif@aol.com 

      Miami Children's Hospital, Miami,  Florida,  33155,  United States; Recruiting
Enrique A. Escalon, MD  305-666-6511 

      Nemours Children's Clinic, Jacksonville,  Florida,  32207,  United States; Recruiting
Eric Sandler, MD  904-390-3793    esandler@nemours.org 

      Nemours Children's Clinic-Orlando, Orlando,  Florida,  32806,  United States; Recruiting
Vincent F. Giusti, MD  407-650-7230 

      Sacred Heart Children's Hospital, Pensacola,  Florida,  32504,  United States; Recruiting
John F. Kelleher, MD  850-505-4798    jfkelleh@neumous.org 

      St. Joseph's Children's Hospital, Tampa,  Florida,  33677-4227,  United States; Recruiting
Cameron K. Tebbi, MD  813-870-4252    cameron.tebbi@baycare.org 

      St. Mary's Hospital, West Palm Beach,  Florida,  33407,  United States; Recruiting
Narayana Gowda, MD  561-840-6125    doctorgowda@hotmail.com 

      University of Florida Shands Cancer Center, Gainesville,  Florida,  32610-0296,  United States; Recruiting
Stephen P. Hunger, MD  352-392-5633    hungersp@peds.ufl.edu 

Georgia
      AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus, Atlanta,  Georgia,  30342,  United States; Recruiting
Howard M. Katzenstein, MD  404-785-0853    howard.katzenstein@choa.org 

      Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah,  Georgia,  31405,  United States; Recruiting
Tribhawan S. Vats, MD  912-350-8194    vatsri@memorialhealth.com 

      MBCCOP-Medical College of Georgia Cancer Center, Augusta,  Georgia,  30912-4000,  United States; Recruiting
Roger A. Vega, MD  706-721-3626 

      Medical Center of Central Georgia, Macon,  Georgia,  31201,  United States; Recruiting
Hassan Dannawi, MD  478-633-1104    dannawi.hassan@mccg.org 

Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Robert Warren Wilkinson, MD  808-586-2979 

      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Brian F. Issell, MD  808-586-3015    brian@crch.hawaii.edu 

      Tripler Army Medical Center, Honolulu,  Hawaii,  96859-5000,  United States; Recruiting
Braden Alan Shoupe, MD  808-433-6057 

Idaho
      Mountain States Tumor Institute - Boise, Boise,  Idaho,  83712,  United States; Recruiting
J. Martin Johnston, MD  208-381-2782    johnstom@slrmc.org 

Illinois
      Advocate Hope Children's Hospital, Oak Lawn,  Illinois,  60453,  United States; Recruiting
Sharad N. Salvi, MD  708-346-4094    sharad.salvi@advocatehealth.com 

      Children's Memorial Hospital - Chicago, Chicago,  Illinois,  60614,  United States; Recruiting
Susan Lerner Cohn, MD  773-880-4562 

      Lutheran General Cancer Care Center, Park Ridge,  Illinois,  60068-1174,  United States; Recruiting
Jong-Hyo Kwon, MD  847-723-5962    jong-hyo.kwon_md@advocatehealth.com 

      Rush University Medical Center, Chicago,  Illinois,  60612,  United States; Recruiting
Allen D. Korenblit, MD  312-942-5983    akorenbl@rush.edu 

      Saint Jude Midwest Affiliate, Peoria,  Illinois,  61637,  United States; Recruiting
John A. McCallister, MD  309-624-4945    john.mccallister@stjude.org 

      Southern Illinois University School of Medicine, Springfield,  Illinois,  62794-9658,  United States; Recruiting
Gregory Brandt, MD  217-545-5817    gbrandt@siumed.edu 

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60601,  United States; Recruiting
James B. Nachman, MD  773-702-6808 

      University of Illinois Medical Center, Chicago,  Illinois,  60612,  United States; Recruiting
Mary Lou Schmidt, MD  312-996-6143    mls3@uic.edu 

Indiana
      Riley Children Cancer Center at Riley Hospital for Children, Indianapolis,  Indiana,  46202-5225,  United States; Recruiting
Robert Fallon, MD, PhD  317-274-8784    rfallon@iupui.edu 

      St. Vincent Hospitals and Health Care Centers, Indianapolis,  Indiana,  46260,  United States; Recruiting
Randy Alan Hock, MD, PhD, MMM  317-338-4673 

Iowa
      Blank Children's Hospital, Des Moines,  Iowa,  50308,  United States; Recruiting
Torrey Leighton Mitchell, MD  515-241-8912    mitchetl@ihs.org 

      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States; Recruiting
Raymond Tannous, MD  319-356-1905 

      John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines,  Iowa,  50309,  United States; Recruiting
Stephen C. Elliott, DO, PhD, FAAP  515-241-6000    elliotsc@ihs.org 

Kansas
      Wesley Medical Center, Wichita,  Kansas,  67214,  United States; Recruiting
David Rosen, MD  316-962-2025 

Kentucky
      Kosair Children's Hospital, Louisville,  Kentucky,  40202-3830,  United States; Recruiting
Salvatore J. Bertolone, MD  502-852-8450 

      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0284,  United States; Recruiting
Martha F. Greenwood, MD  859-323-6771    mfgree0@pop.uky.edu 

Louisiana
      Children's Hospital of New Orleans, New Orleans,  Louisiana,  70118,  United States; Recruiting
Lolie Chua Yu, MD  504-896-9740 

      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Jill Gilbert, MD  504-568-5613    jgilbe@lsuhsc.edu 

      Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States; Recruiting
Marquis Zimri Hodes, MD, PhD  504-842-5230 

      Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112,  United States; Recruiting
Marshall A. Schorin, MD  504-988-5412    mschori@tulane.edu 

Maine
      CancerCare of Maine at Eastern Maine Medial Center, Bangor,  Maine,  04401,  United States; Recruiting
Judith B. Allen, MD  207-973-7520 

      Maine Children's Cancer Program, Scarborough,  Maine,  04074-9308,  United States; Recruiting
Craig A. Hurwitz, MD  207-885-7565    hurwic@mmc.org 

Maryland
      Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore,  Maryland,  21215,  United States; Recruiting
Joseph Michael Wiley, MD  410-601-5864    jwiley@lifebridehealth.org 

      Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore,  Maryland,  21201-1595,  United States; Recruiting
Neil Jeffrey Grossman, MD  410-328-2808    ngrossma@peds.umaryland.edu 

      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States; Recruiting
Cindy Schwartz, MD  410-955-7385    schwac@ijhmi.edu 

      Walter Reed Army Medical Center, Silver Spring,  Maryland,  20910,  United States; Recruiting
Kip R. Hartman, MD  301-319-9116 

Massachusetts
      Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield,  Massachusetts,  01107,  United States; Recruiting
David A. Steele, MD  413-794-9338    david.steele@bhs.org 

      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
Holcombe Edwin Grier, MD  617-632-3971    holcombe-grier@dfci.harvard.edu 

      Floating Hospital for Children, Boston,  Massachusetts,  02111,  United States; Recruiting
Cynthia S. Kretschmar, MD  617-636-5535    ckretschmar@tufts-nemc.org 

      UMASS Memorial Cancer Center - University Campus, Worcester,  Massachusetts,  01655,  United States; Recruiting
Ghazala Naheed Usmani, MD  508-856-4225    usmanin@ummhc.org 

Michigan
      Breslin Cancer Center at Ingham Regional Medical Center, Lansing,  Michigan,  48910,  United States; Recruiting
Renuka Gera, MD  517-334-2337 

      Bronson Methodist Hospital, Kalamazoo,  Michigan,  49007-5364,  United States; Recruiting
Leonard August Mattano, MD, PhD  616-341-6350 

      CCOP - Beaumont, Royal Oak,  Michigan,  48073-6769,  United States; Recruiting
Jeanne Archer, PhD, APN  248-551-8299    carcher@beaumon.edu 

      Children's Hospital of Michigan, Detroit,  Michigan,  48201,  United States; Recruiting
Yaddanapudi Ravindranath, MBBS  313-745-5649    ravi@med.wayne.edu 

      DeVos Children's Hospital, Grand Rapids,  Michigan,  49503,  United States; Recruiting
David Robert Freyer, DO  616-391-2086 

      Hurley Medical Center, Flint,  Michigan,  48503,  United States; Recruiting
Susumu Inoue, MD  810-762-7303    sinoue1@hurleymc.com 

      Josephine Ford Cancer Center at Henry Ford Health System, Detroit,  Michigan,  48202,  United States; Recruiting
Hassan M. Yaish, MD  313-916-3138 

      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0914,  United States; Recruiting
Raymond J. Hutchinson, MD  734-936-8785 

      Van Elslander Cancer Center at St. John Hospital and Medical Center, Detroit,  Michigan,  48236,  United States; Recruiting
Hadi Sawaf, MD  313-647-3200    hadi.sawaf@stjohn.org 

      William Beaumont Hospital - Royal Oak, Royal Oak,  Michigan,  48073-6769,  United States; Recruiting
Charles A. Main, MD  248-551-0360 

Minnesota
      Children's Hospitals and Clinics - Minneapolis/St. Paul, Minneapolis,  Minnesota,  55404,  United States; Recruiting
Maura C. O'Leary, MD  612-813-5940 

      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Carola A.S. Arndt, MD  507-284-2511    carndt@mayo.edu 

      St. Mary's - Duluth Clinic Cancer Center, Duluth,  Minnesota,  55805,  United States; Recruiting
Jacquelyn Dawn Wiermaa, MD  218-786-3625 

Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States; Recruiting
Dale Jeanette Pullen, MD  601-984-5220 

Missouri
      Cardinal Glennon Children's Hospital, Saint Louis,  Missouri,  63104,  United States; Recruiting
William Shay Ferguson, MD  314-577-5638 

      Children's Mercy Hospital, Kansas City,  Missouri,  64108,  United States; Recruiting
Maxine L. Hetherington, MD  816-234-3265 

      St. Louis Children's Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
Robert James Hayashi, MD  314-454-4118    hayashi_r@kids.wustl.edu 

      University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
Barbara Anne Gruner, MD  573-882-3961    grunerb@health.missousri.edu 

Nebraska
      Children's Hospital of Omaha, Omaha,  Nebraska,  68114,  United States; Recruiting
Minnie Abromowitch, MD  402-955-3949    mabromo@unmc.edu 

      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-2168,  United States; Recruiting
Peter F. Coccia, MD  402-559-7257    pcoccia@unmc.edu 

Nevada
      Sunrise Hospital and Medical Center, Las Vegas,  Nevada,  89109,  United States; Recruiting
Jonathan Bernstein, MD  702-732-0971    jonbern1@aol.com 

New Hampshire
      Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756,  United States; Recruiting
Eric Christian Larsen, MD  603-650-5541    eric.c.larsen@hitchcock.org 

New Jersey
      Cancer Center at Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States; Recruiting
Michael B. Harris, MD  201-996-5437    mbharris@humed.com 

      Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick,  New Jersey,  08903,  United States; Recruiting
Richard A. Drachtman, MD  732-235-5437    drachtri@umdnj.edu 

      Newark Beth Israel Medical Center, Newark,  New Jersey,  07112-2094,  United States; Recruiting
Peri Kamalakar, MD  973-926-7161    pkamalak@sghcs.com 

      St. Joseph's Hospital and Medical Center, Paterson,  New Jersey,  07503,  United States; Recruiting
Mary Ann Bonilla, MD  973-754-3230    bonillam@sjhmc.org 

      Valerie Fund Children's Center at Atlantic Health, Summit,  New Jersey,  07901,  United States; Recruiting
Hazem Helmy Mahmoud, MD  973-971-6731 

New Mexico
      University of New Mexico Cancer Research and Treatment Center, Albuquerque,  New Mexico,  87131,  United States; Recruiting
Jami Frost, MD  505-272-4461 

New York
      Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx,  New York,  10461,  United States; Recruiting
Eva Radel, MD  718-920-7844 

      Brookdale University Hospital and Medical Center, Brooklyn,  New York,  11212,  United States; Recruiting
Kusum Viswanathan, MD  718-240-5904 

      Brooklyn Hospital Center, Brooklyn,  New York,  11201-5493,  United States; Recruiting
Swayamprabha Sadanandan, MD  718-250-6074    sws9001@nyp.org 

      Cancer Center of Albany Medical Center, Albany,  New York,  12208,  United States; Recruiting
Jennifer M. Pearce, MD  518-262-5513    pearcej@mail.amc.edu 

      Comprehensive Cancer Center at Maimonides Medical Center, Brooklyn,  New York,  11219,  United States; Recruiting
Ludovico Guarini, MD  718-283-8173    lguarini@maimonidesmed.org 

      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting
Linda Granowetter, MD  212-305-8652    lg519@columbia.edu 

      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
Barbara Lawrence Asselin, MD  716-275-2981 

      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11794,  United States; Recruiting
Robert Ingalls Parker, DSc  631-444-4000 

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Peter G. Steinherz, MD  212-639-7951 

      Mount Sinai School of Medicine, New York,  New York,  10029,  United States; Recruiting
Elizabeth Raetz, MD  212-241-7022 

      New York Medical College, Valhalla,  New York,  10595,  United States; Recruiting
M. Fevzi Ozkaynak, MD  914-493-7997    mehmet_ozkaynak@nymc.edu 

      New York Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  United States; Recruiting
Patricia J.V. Giardina, MD  212-746-3400 

      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting
Martin L. Brecher, MD  716-845-2333    martin.brecher@roswellpark.org 

      Schneider Children's Hospital, New Hyde Park,  New York,  11042,  United States; Recruiting
Arlene Sara Redner, MD  718-470-3460 

      SUNY Downstate Medical Center, Brooklyn,  New York,  11203,  United States; Recruiting
Sreedhar P. Rao, MD  718-270-1693 

      SUNY Upstate Medical University Hospital, Syracuse,  New York,  13210,  United States; Recruiting
Ronald L. Dubowy, MD  315-464-5294    dubowyr@upstate.edu 

North Carolina
      Blumenthal Cancer Center at Carolinas Medical Center, Charlotte,  North Carolina,  28232-2861,  United States; Recruiting
Daniel P. McMahon, MD  704-355-1130    dmcmahon@carolinas.org 

      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1081,  United States; Recruiting
Thomas Williams McLean, MD  336-716-4324 

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
Philip Paul Breitfeld, MD  919-684-3377 

      Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital, Greenville,  North Carolina,  27858-4354,  United States; Recruiting
Charles W. Daeschner, MD  252-744-4676    DaeschnerC@mail.ecu.edu 

      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599,  United States; Recruiting
Stuart Gold, MD  919-966-0985    stubaby@med.unc.med 

      Mission Hospitals, Asheville,  North Carolina,  28801,  United States; Recruiting
Orren Beaty, DO, PhD  823-213-5770    orren.beaty@msj.org 

      Presbyterian Cancer Center at Presbyterian Hospital, Charlotte,  North Carolina,  28233,  United States; Recruiting
Mark Mogul, MD  704-384-1900 

North Dakota
      Dakota Cancer Institute at Innovis Health - Dakota Clinic, Fargo,  North Dakota,  58103-4940,  United States; Recruiting
Janet K. Tillisch, MD  701-364-4964 

Ohio
      Children's Hospital Medical Center of Akron, Akron,  Ohio,  44308-1062,  United States; Recruiting
Steven J. Kuerbitz, MD  330-543-8730    skuerbitz@chmca.org 

      Children's Medical Center - Dayton, Dayton,  Ohio,  45404,  United States; Recruiting
Emmett H. Broxson, MD, FAAP  937-641-3111    broxsone@childrensdayton.org 

      Cincinnati Children's Hospital Medical Center, Cincinnati,  Ohio,  45229-3039,  United States; Recruiting
John Peter Perentesis, MD  513-636-6090 

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States; Recruiting
Karen A. Bringelsen, MD  216-444-7923 

      Columbus Children's Hospital, Columbus,  Ohio,  43205-2696,  United States; Recruiting
Amanda Termuhlen, MD  614-722-3552 

      Forum Health-Tod Childrens Hospital, Youngstown,  Ohio,  44501,  United States; Recruiting
Ayman Saleh, MD, FAAP  330-884-3955    asaleh@neoucom.edu 

      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-5065,  United States; Recruiting
Susan Wiersma, MD  216-844-3345    srw3@po.cwru.edu 

      St. Vincent Mercy Medical Center, Toledo,  Ohio,  43608,  United States; Recruiting
Rama Jasty, MD  419-251-8215    rjasty@mco.edu 

      Toledo Children's Hospital, Toledo,  Ohio,  43601,  United States; Recruiting
Richard M. Shore, MD  419-471-5437 

Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States; Recruiting
James B. Lockhart, MD  918-491-5878 

      Children's Hospital at Oklahoma University Medical Center, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
William H. Meyer, MD  405-271-5311    william-meyer@ouhsc.edu 

      Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa,  Oklahoma,  74136,  United States; Recruiting
Martina Christine Hum, MD  918-494-2525    pedonc@saintfrancis.com 

Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Keith S. Lanier, MD  503-216-6260 

      Doernbecher Children's Hospital at Oregon Health & Science University, Portland,  Oregon,  97239-3098,  United States; Recruiting
H. Stacy Nicholson, MD, MPH  503-494-1543 

      Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland,  Oregon,  97227,  United States; Recruiting
Janice Faye Olson, MD  503-413-2200 

Pennsylvania
      Children's Hospital at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States; Recruiting
John E. Neely, MD  717-531-6012    jen6@psu.edu 

      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Richard Berry Womer, MD  215-590-2229    rwomer@mail.med.upenn.edu 

      Children's Hospital of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Arthur Kim Ritchey, MD  412-692-5055    kim.ritchey@chp.edu 

      Geisinger Medical Center, Danville,  Pennsylvania,  17822-1320,  United States; Recruiting
Jeffrey Taylor, MD  570-271-6848 

      St. Christopher's Hospital for Children, Philadelphia,  Pennsylvania,  19134-1095,  United States; Recruiting
Gregory E. Halligan, MD  215-427-5000    Gregory.Halligan@tenethealth.com 

Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States; Recruiting
Sam W. Lew, MD  401-444-5171 

South Carolina
      Children's Hospital of Greenville Hospital System, Greenville,  South Carolina,  29605,  United States; Recruiting
Cary Ernest Stroud, MD  864-455-8898 

      Hollings Cancer Center at Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States; Recruiting
Julio C. Barredo, MD  843-792-2957    barredjc@musc.edu 

      Palmetto Health South Carolina Cancer Center, Columbia,  South Carolina,  29203,  United States; Recruiting
Ronnie W. Neuberg, MD  803-434-3533    ronnie.neuberg@palmettohealth.org 

South Dakota
      Avera Cancer Institute, Sioux Falls,  South Dakota,  57105-1080,  United States; Recruiting
Marwan D. Hanna, MD  605-322-7595 

      Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls,  South Dakota,  57117-5039,  United States; Recruiting
Jakica Tancabelic, MD  605-333-7171    jtancabe@usd.edu 

Tennessee
      East Tennessee Children's Hospital, Knoxville,  Tennessee,  37901,  United States; Recruiting
Ray C. Pais, MD  865-541-8266    hemonc@etch.com 

      East Tennessee State University Cancer Center at Johnson City Medical Center, Johnson City,  Tennessee,  37614-0622,  United States; Recruiting
David K. Kalwinsky, MD  423-433-6200    sjcrhta@msha,cin 

      St. Jude Children's Research Hospital, Memphis,  Tennessee,  38105-2794,  United States; Recruiting
Wayne Lee Furman, MD  901-495-3300 

      Vanderbilt Children's Hospital, Nashville,  Tennessee,  37232-6310,  United States; Recruiting
James A. Whitlock, MD  615-936-1762 

Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
C. Philip Steuber, MD  713-798-6970 

      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
Lucas Wong, MD  254-724-1053    lwong@swmail.sw.org 

      Center for Cancer Prevention and Care at Scott and White Clinic, Temple,  Texas,  76508,  United States; Recruiting
Dick Suh, MD, PhD  254-724-9852    DSuh@swmail.sw.org 

      Children's Hospital of Austin, Austin,  Texas,  78701,  United States; Recruiting
Sharon K. Lockhart, MD  512-324-8480    slockhart@stcaustin.com 

      Cook Children's Medical Center - Fort Worth, Fort Worth,  Texas,  76104,  United States; Recruiting
Timothy C. Griffin, MD  682-885-4020    TGriffin@cookchildrens.org 

      Covenant Children's Hospital, Lubbock,  Texas,  79410,  United States; Recruiting
John Iacuone, MD  806-725-4840 

      MBCCOP - South Texas Pediatrics, San Antonio,  Texas,  78229-3900,  United States; Recruiting
Anne-Marie Langevin, MD  210-704-3405    langevin@uthscsa.edu 

      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
Joann Ater, MD  713-792-6665    jater@mdanderson.org 

      Medical City Dallas Hospital, Dallas,  Texas,  75230,  United States; Recruiting
Carl Lenarsky, MD  972-566-6647    carl.lenarsky@usoncology.com 

      Methodist Cancer Center at Methodist Specialty and Transplant Hospital, San Antonio,  Texas,  78229-3902,  United States; Recruiting
Jaime Estrada, MD  210-575-8130 

      San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base,  Texas,  78236,  United States; Recruiting
Aaron Pitney, MD  210-292-5684 

      Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas,  Texas,  75390-9063,  United States; Recruiting
Naomi J. Winick, MD  214-648-3074    naomi.winick@utsouthwestern.edu 

      Texas Tech University Health Sciences Center School of Medicine, Amarillo,  Texas,  79106,  United States; Recruiting
Curtis Wade Turner, MD  806-354-5434    curtis.turner@ttuhsc.edu 

      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78207,  United States; Recruiting
Paul Jan Thomas, MD  210-704-3405    thomasp@uthscsa.edu 

      University of Texas Medical Branch, Galveston,  Texas,  77555-0209,  United States; Recruiting
Frederick Szujuei Huang, MD  409-772-2341    fshuang@utmb.edu 

Utah
      Huntsman Cancer Institute at University of Utah, Salt Lake City,  Utah,  84112,  United States; Recruiting
Carol S. Bruggers, MD  801-585-0303 

Vermont
      Vermont Cancer Center at University of Vermont, Burlington,  Vermont,  05401-3498,  United States; Recruiting
Alan C. Homans, MD  802-847-2850 

Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States; Recruiting
Kimberly Dunsmore, MD  434-924-9333 

      Carilion Medical Center for Children at Roanoke Community Hospital, Roanoke,  Virginia,  24029,  United States; Recruiting
Joan Mistretta Fisher, MD, PhD  540-985-8055    jmfisher@carilion.com 

      Children's Hospital of the King's Daughters, Norfolk,  Virginia,  23507,  United States; Recruiting
Rebecca L. Byrd, MD  757-668-7243    byrdrl@chkd.org 

      INOVA Fairfax Hospital, Falls Church,  Virginia,  22042-3300,  United Sta

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000315540; COG-AOST0221; NCT00066365
Record last reviewed:  July 2004
Last Updated:  March 28, 2005
Record first received:  August 6, 2003
ClinicalTrials.gov Identifier:  NCT00066365
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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