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Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Neuroblastoma

This study has been completed.

Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00017368
  Purpose

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

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have newly diagnosed neuroblastoma.


Condition Intervention Phase
Neuroblastoma
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: etoposide phosphate
Drug: filgrastim
Drug: ifosfamide
Drug: isotretinoin
Drug: melphalan
Drug: sargramostim
Drug: thiotepa
Drug: vincristine sulfate
Procedure: conventional surgery
Procedure: peripheral blood stem cell transplantation
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Neuroblastoma   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride    Ifosfamide    Cyclophosphamide    Carboplatin    Filgrastim    Etoposide    Cisplatin    Melphalan    Vincristine sulfate    Vincristine    Thiotepa    Isotretinoin    Sargramostim    Granulocyte-macrophage colony-stimulating factor    Etoposide phosphate    Melphalan hydrochloride    Sarcolysin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Pilot Study Of Tandem High Dose Chemotherapy With Stem Cell Rescue Following Induction Therapy In Children With High Risk Neuroblastoma

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

Study Start Date:   April 2001

Show detailed description  Show Detailed Description

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

Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed high-risk neuroblastoma

    • Histologically proven AND/OR
    • Bone marrow specimen showing clumps of tumor cells accompanied by elevated urinary catecholamines
    • Age 1-30:

      • Must meet one of the following INSS staging criteria:

        • Stage IV regardless of biologic factors
        • Stage IIa/IIb with MYCN oncogene amplification (greater than 10) and unfavorable pathology
        • Stage III with MYCN oncogene amplification (greater than 10) or unfavorable pathology
        • Initially stage I, II, or IVS, that has progressed without interval chemotherapy
    • Under age 1:

      • INSS stage III, IV, or IVS with MYCN amplification (greater than 10)
  • Must enter neuroblastoma biology study COG-ANBL00B1 within 2 weeks of diagnosis and before entry on this study

PATIENT CHARACTERISTICS:

Age:

  • 30 and under at original diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No more than 1 prior course of chemotherapy on the intergroup low- or intermediate-risk neuroblastoma studies prior to determination of MYCN status and Shimada histology

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior emergent radiotherapy to sites of function- or life-threatening neuroblastoma allowed

Surgery:

  • Not specified

Other:

  • No other prior systemic therapy for neuroblastoma
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017368

Locations
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish RiteCampus    
      Atlanta, Georgia, United States, 30342
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute    
      Boston, Massachusetts, United States, 02115
Floating Hospital for Children    
      Boston, Massachusetts, United States, 02111
United States, Oregon
CCOP - Columbia River Oncology Program    
      Portland, Oregon, United States, 97225
United States, Pennsylvania
Children's Hospital of Philadelphia    
      Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine    
      Houston, Texas, United States, 77030
CCOP - Scott and White Hospital    
      Temple, Texas, United States, 76508
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation    
      Marshfield, Wisconsin, United States, 54449
Australia, Western Australia
Princess Margaret Hospital for Children    
      Perth, Western Australia, Australia, 6001

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Stephen A. Grupp, MD, PhD     Children's Hospital of Philadelphia    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   CDR0000068681, COG-ANBL00P1
First Received:   June 6, 2001
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00017368
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Melphalan
Neuroectodermal Tumors, Primitive
Vincristine
Carboplatin
Cyclophosphamide
Etoposide phosphate
Neuroblastoma
Doxorubicin
Thiotepa
Neuroectodermal Tumors
Ifosfamide
Cisplatin
Neoplasms, Germ Cell and Embryonal
Isotretinoin
Neuroepithelioma
Etoposide
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial
Isophosphamide mustard

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Antimitotic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Antirheumatic Agents
Dermatologic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on December 03, 2008




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