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Therapy for Children With Advanced Stage High Risk Neuroblastoma

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ClinicalTrials.gov Identifier: NCT00186849
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 20, 2009
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
St. Jude Children's Research Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Neuroblastoma Drug: Topotecan, Cyclophosphamide, Cisplatin, Doxorubicin, Etoposide, Ifosfamide, Carboplatin Procedure: Peripheral Blood Stem Cell Transplant Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapy for Children With Advanced Stage High Risk Neuroblastoma
Study Start Date : October 1997
Actual Primary Completion Date : April 2001
Actual Study Completion Date : April 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Arm Intervention/treatment
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.




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

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 20, 2009
Last Verified: May 2009

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
Cyclophosphamide
Ifosfamide
Carboplatin
Doxorubicin
Etoposide
Topotecan
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic