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Therapy for Children With Advanced Stage High Risk Neuroblastoma

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00186849
First received: September 12, 2005
Last updated: May 19, 2009
Last verified: May 2009
History of Changes
  Purpose

This is a Phase II pilot study of chemotherapy and surgery for children with advanced stage high-risk neuroblastoma utilizing topotecan during an upfront window and other active agents during induction and intensification phases. The primary purpose is to estimate the response rate to an upfront window of two cycles of intravenous topotecan. We hypothesize that the topotecan window will be an effective therapy in terms of the response rate.


Condition Intervention Phase
Neuroblastoma
 Drug: Topotecan, Cyclophosphamide, Cisplatin, Doxorubicin, Etoposide, Ifosfamide, Carboplatin
Procedure: Peripheral Blood Stem Cell Transplant
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapy for Children With Advanced Stage High Risk Neuroblastoma

Resource links provided by NLM:

MedlinePlus related topics: Neuroblastoma
U.S. FDA Resources

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Response rate [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Feasibility/toxicity of an intensification phase of high-dose chemotherapy with topotecan and cyclophosphamide followed by autologous peripheral blood stem cell transplant [ Time Frame: 5 years ]

Enrollment: 30
Study Start Date: October 1997
Study Completion Date: April 2001
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Topotecan, Cyclophosphamide, Cisplatin, Doxorubicin, Etoposide, Ifosfamide, Carboplatin
See Detailed Description section for details of treatment interventions.
Procedure: Peripheral Blood Stem Cell Transplant
See Detailed Description section for details of treatment interventions.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced stage,high-risk neuroblastoma
  • Histologic proof of neuroblastoma
  • Adequate renal function
  • ECOG performance status 0-2

Exclusion Criteria:

  • Previous therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186849

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
National Institutes of Health (NIH)
Investigators
Principal Investigator: Wayne L. Furman, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
St. Jude Children's Research Hospital  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Wayne L. Furman, MD / Principal Investigator, St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00186849     History of Changes
Other Study ID Numbers: NB-97
Study First Received: September 12, 2005
Last Updated: May 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cisplatin
Cyclophosphamide
Doxorubicin
Etoposide
Ifosfamide
 Carboplatin
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on May 21, 2013