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Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
This study has been completed.
First Received: January 21, 2000   Last Updated: February 6, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004188
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: This randomized phase III trial is studying peripheral stem cell transplantation with treated peripheral stem cells following combination chemotherapy to see how well it works compared to peripheral stem cell transplantation with untreated peripheral stem cells following combination chemotherapy in treating patients with neuroblastoma.


Condition Intervention Phase
Neuroblastoma
Biological: filgrastim
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: isotretinoin
Drug: melphalan
Drug: topotecan hydrochloride
Drug: vincristine sulfate
Procedure: autologous bone marrow transplantation
Procedure: bone marrow ablation with stem cell support
Procedure: conventional surgery
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to engrafment [ Designated as safety issue: No ]
  • CD34 content [ Designated as safety issue: No ]
  • Tumor content as measured by reverse transcriptase polymerase chain reaction [ Designated as safety issue: No ]

Study Start Date: February 2001
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed neuroblastoma OR ganglioneuroblastoma, and/or evidence of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, meeting 1 of the following criteria:

    • Age greater than 18 months with stage IV disease, regardless of biologic factors
    • Age 12-18 months with stage IV disease meeting one of the following criteria:

      • Any unfavorable biologic feature (e.g., MYCN amplification, unfavorable pathology, and/or DNA index = 1)
      • Any biologic feature that is indeterminate, unsatisfactory, or unknown
  • At least 1 year old with the following:

    • Stage IIa/IIb with MYCN amplification (> 10) AND unfavorable pathology
    • Stage III with MYCN amplification (> 10) OR unfavorable pathology
    • Stage I, II, or IVS with disease progression to stage IV without interval chemotherapy

      • No more than 3 weeks since progression
      • Must have been enrolled on protocol CCG-B973, COG-ANBL00B1, or POG-9047
  • Less than 1 year old with the following:

    • Stage III, IV, or IVS disease with MYCN amplification (> 10)
  • Registration on protocol COG-ANBL00B1 required within 14 days of diagnosis

PATIENT CHARACTERISTICS:

Age:

  • See Disease Characteristics
  • 30 and under at time of diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Inadequate hematopoiesis secondary to bone marrow involvement with > 10% tumor infiltration allowed

Hepatic:

  • Bilirubin ≤ 1.5 mg/dL
  • ALT ≤ 300 units/L

Renal:

  • Creatinine ≤ 1.5 mg/dL
  • Creatinine clearance or glomerular filtration rate ≥ 60 mL/min

Cardiovascular:

  • ECG normal
  • Ejection fraction ≥ 55% by echocardiogram or MUGA OR
  • Fractional shortening ≥ 28% by echocardiogram

Other:

  • Able to tolerate peripheral blood stem cell collection
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for at least 1 month prior to, during, and for 1 month after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No more than 1 prior course of chemotherapy on the Intergroup low/intermediate risk neuroblastoma study (P9641, A3961)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior localized emergency radiotherapy to sites of life-threatening or function-threatening disease allowed

Surgery:

  • Not specified

Other

  • No other prior systemic therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004188

  Hide Study Locations
Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
United States, California
Children's Hospital and Health Center - San Diego
San Diego, California, United States, 92123-4282
Children's Hospital Central California
Madera, California, United States, 93638-8762
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States, 90801
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048-1865
Southern California Permanente Medical Group
Downey, California, United States, 90242-2814
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States, 95825
United States, Colorado
Children's Hospital Cancer Center
Denver, Colorado, United States, 80218-1088
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-2875
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Florida
All Children's Hospital
St. Petersburg, Florida, United States, 33701
Broward General Medical Center Cancer Center
Ft. Lauderdale, Florida, United States, 33316
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States, 33901
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States, 33607
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
United States, Illinois
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9620
University of Illinois at Chicago Cancer Center
Chicago, Illinois, United States, 60612-7243
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1083
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40232
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0084
United States, Maine
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States, 04401
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
C.S. Mott Children's Hospital at University of Michigan
Ann Arbor, Michigan, United States, 48109-0238
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-5341
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, United States, 49503-2560
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
United States, Minnesota
Children's Hospital of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Siteman Cancer Center at Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, Nebraska
Children's Hospital of Omaha
Omaha, Nebraska, United States, 68114-4113
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, Nevada
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109-2306
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
New York Medical College
Valhalla, New York, United States, 10595
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
United States, Ohio
Children's Medical Center - Dayton
Dayton, Ohio, United States, 45404-1815
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-5217
Columbus Children's Hospital
Columbus, Ohio, United States, 43205-2696
Medical College of Ohio Cancer Institute
Toledo, Ohio, United States, 43614
Toledo Hospital
Toledo, Ohio, United States, 43606
United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States, 29203
United States, South Dakota
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
East Tennessee Children's Hospital
Knoxville, Tennessee, United States, 37916
United States, Texas
Children's Hospital of Austin
Austin, Texas, United States, 78701
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104-9958
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States, 79106
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05405
United States, Virginia
Carilion Cancer Center of Western Virginia
Roanoke, Virginia, United States, 24029
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0037
United States, Washington
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States, 99220-2555
United States, West Virginia
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
Canada, British Columbia
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Children's Hospital of Western Ontario
London, Ontario, Canada, N6A 4G5
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, Canada, G1V 4G2
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H3H 1P3
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Susan G. Kreissman, MD Duke University
  More Information

Additional Information:
Publications:
Kreissman SG, Villablanca JG, Diller L, et al.: Response and toxicity to a dose-intensive multi-agent chemotherapy induction regimen for high risk neuroblastoma (HR-NB): a Children's Oncology Group (COG A3973) study. [Abstract] J Clin Oncol 25 (Suppl 18): A-9505, 527s, 2007.
Cantos MF, Gerstle JT, Irwin MS, Pappo A, Farley S, Cheang T, Kim PC. Surgical challenges associated with intensive treatment protocols for high-risk neuroblastoma. J Pediatr Surg. 2006 May;41(5):960-5.
Kushner BH, Budnick A, Kramer K, Modak S, Cheung NK. Ototoxicity from high-dose use of platinum compounds in patients with neuroblastoma. Cancer. 2006 Jul 15;107(2):417-22.

Study ID Numbers: CDR0000067429, COG-A3973, CCG-A3973, POG-A3973, CCG-39703, FHCRC-1631.00
Study First Received: January 21, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004188     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized resectable neuroblastoma
regional neuroblastoma
disseminated neuroblastoma
stage 4S neuroblastoma
localized unresectable neuroblastoma

Additional relevant MeSH terms:
Melphalan
Neuroectodermal Tumors, Primitive
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Cyclophosphamide
Antibiotics, Antineoplastic
Neuroblastoma
Cisplatin
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Isotretinoin
Dermatologic Agents
Alkylating Agents
Etoposide
Neoplasms by Histologic Type
Mitosis Modulators
Vincristine
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Radiation-Sensitizing Agents
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2009