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Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), September 2008

Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00567567
  Purpose

RATIONALE: 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 combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known which regimen of myeloablation chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.

PURPOSE: This randomized phase III trial is comparing two different myeloablation therapies followed by a stem cell transplant in treating young patients with high-risk neuroblastoma.


Condition Intervention Phase
Neuroblastoma
Drug: carboplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: melphalan
Drug: thiotepa
Phase III

MedlinePlus related topics:   Cancer    Neuroblastoma   

ChemIDplus related topics:   Cyclophosphamide    Carboplatin    Etoposide    Melphalan    Thiotepa    Etoposide phosphate    Melphalan hydrochloride    Sarcolysin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma

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

Primary Outcome Measures:
  • Event-free survival rate [ Designated as safety issue: No ]
  • Response after induction therapy [ Designated as safety issue: No ]
  • Incidence rate of local recurrence [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of ≥ grade 3 neutropenia during course one [ Designated as safety issue: No ]
  • Duration of ≥ grade 3 thrombocytopenia during course one [ Designated as safety issue: No ]
  • Response rate after two courses of induction therapy [ Designated as safety issue: No ]

Estimated Enrollment:   495
Study Start Date:   November 2007
Estimated Primary Completion Date:   March 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Consolidation therapy arm I: Active Comparator
(Single myeloablative transplantation): Patients receive melphalan IV over 15-30 minutes on days -7 to -5, etoposide IV over 24 hours and carboplatin IV over 24 hours on days -7 to -4.
Drug: carboplatin
Given IV
Drug: etoposide
Given IV
Drug: melphalan
Given IV
Consolidation therapy arm II: Experimental
(Tandem myeloablative transplantation): Patients receive thiotepa IV over 2 hours on days -7 to -5, cyclophosphamide IV over 1 hour on days -5 to -2. Patients also receive melphalan, etoposide, and carboplatin as in arm I.
Drug: carboplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: etoposide
Given IV
Drug: melphalan
Given IV
Drug: thiotepa
Given IV

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:

  • Diagnosis of neuroblastoma or ganglioneuroblastoma by histology or as evidenced by the presence of clumps of tumor cells in bone marrow and elevated catecholamine metabolites in urine meeting any of the following criteria:

    • Patients with newly diagnosed neuroblastoma with International Neuroblastoma Staging System (INSS) stage 4 disease are eligible with the following:

      • MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
      • Age > 18 months (i.e., > 547 days) regardless of biologic features
      • Age 12-18 months (i.e., 365-547 days) with any of the following three unfavorable biologic features (i.e., MYCN amplification, unfavorable pathology, and/or DNA index = 1) or any biologic feature that is indeterminant, unsatisfactory, or unknown
    • Patients with newly diagnosed neuroblastoma with INSS stage 3 are eligible with the following:

      • MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
      • Age > 18 months (i.e., > 547 days) with unfavorable pathology, regardless of MYCN status
    • Patients with newly diagnosed INSS stage 2a or 2b with MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
    • Patients with newly diagnosed INSS stage 4s with MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features
    • Patients ≥ 365 days initially diagnosed with INSS stage 1, 2, or 4S and who progressed to a stage 4 without interval chemotherapy

      • Must have been enrolled on COG-ANBL00B1

PATIENT CHARACTERISTICS:

  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70mL/min OR serum creatinine based on age/gender as follows:

    • 1 month to < 6 months: 0.4 mg/dL
    • 6 months to < 1 year: 0.5 mg/dL
    • 1 to < 2 years: 0.6 mg/dL
    • 2 to < 6 years: 0.8 mg/dL
    • 6 to < 10 years: 1 mg/dL
    • 10 to < 13 years: 1.2 mg/dL
    • 10 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)
    • ≥ 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
  • AST or ALT < 10 times ULN for age
  • Shortening fraction ≥ 27% by ECHO OR LVEF ≥ 50% by radionuclide angiogram
  • No known contraindication (e.g., size, weight or physical condition) to peripheral blood stem cell collection

PRIOR CONCURRENT THERAPY:

  • No prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease
  • No more than one course of chemotherapy per low- or intermediate-risk neuroblastoma therapy prior to determination of MYCN amplification and histology
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567567

Show 113 study locations  Show 113 Study Locations

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

Investigators
Study Chair:     Julie R. Park, MD     Children's Hospital and Regional Medical Center, Seattle    
  More Information


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

Study ID Numbers:   CDR0000576571, COG-ANBL0532
First Received:   December 4, 2007
Last Updated:   September 22, 2008
ClinicalTrials.gov Identifier:   NCT00567567
Health Authority:   Unspecified

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

Study placed in the following topic categories:
Melphalan
Neuroectodermal Tumors, Primitive
Carboplatin
Cyclophosphamide
Etoposide phosphate
Neuroblastoma
Recurrence
Thiotepa
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Etoposide
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

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

ClinicalTrials.gov processed this record on October 03, 2008




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