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Therapy for Children With Neuroblastoma

This study has been completed.

Sponsors and Collaborators: St. Jude Children's Research Hospital
AstraZeneca
National Institutes of Health (NIH)
Information provided by: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00135135
  Purpose

This is a phase II window study of the combination of ZD1839 (gefitinib) and irinotecan in children with high-risk neuroblastoma followed by standard induction chemotherapy, intensification with autologous stem cell transplantation, and an oral maintenance phase with 13-cis-retinoic acid and topotecan. We hypothesize that the ZD1839 (gefitinib) and irinotecan window will be efficacious.


Condition Intervention Phase
Neuroblastoma
Drug: Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid
Procedure: Radiation therapy, Surgery, Peripheral Stem cell transplant
Phase II

MedlinePlus related topics:   Cancer    Neuroblastoma   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride    Carboplatin    Etoposide    Cisplatin    Melphalan    Irinotecan    Irinotecan hydrochloride    Isotretinoin    Topotecan hydrochloride    Topotecan    Etoposide phosphate    ZD1839    Tretinoin    Melphalan hydrochloride    Sarcolysin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Neuroblastoma Protocol 2005: Therapy for Children With Advanced Stage High-Risk Neuroblastoma

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

Primary Outcome Measures:
  • Response rate [ Time Frame: Within 30 days of completion of window therapy. ]

Enrollment:   23
Study Start Date:   August 2005
Study Completion Date:   June 2007
Primary Completion Date:   June 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1 Drug: Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid
See Detailed Description.
Procedure: Radiation therapy, Surgery, Peripheral Stem cell transplant
See Detailed Description.

Show detailed description  Show Detailed Description

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

Criteria

Inclusion Criteria:

  • Patient is less than or equal to 18 years of age
  • Patient is newly diagnosed with high-risk neuroblastoma
  • Patient has adequate kidney and liver function
  • No prior therapy, unless an emergency situation requires local tumor treatment (discuss with PI)

Exclusion Criteria:

  • Known severe hypersensitivity to ZD1839 or any of the excipients of this product
  • Any evidence, as judged by the investigator, of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  • Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.
  • Pregnant or breast feeding (women of child-bearing potential).
  • Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St. John's Wort.
  • Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
  • Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
  • Children with INSS 4 disease, age <12 months with all 3 favorable biologic features (non-amplified MYCN, favorable pathology and DNA index
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135135

Locations
United States, Tennessee
St. Jude Children's Research Hospital    
      Memphis, Tennessee, United States, 38105

Sponsors and Collaborators
St. Jude Children's Research Hospital
AstraZeneca
National Institutes of Health (NIH)

Investigators
Principal Investigator:     Wayne L Furman, MD     St. Jude Children's Research Hospital    
  More Information


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

Responsible Party:   St.Jude Children's Research Hospital ( Wayne L. Furman M.D./Prinicipal Investigator )
Study ID Numbers:   NB2005, AstraZeneca IRUSIERS0389
First Received:   August 24, 2005
Last Updated:   June 2, 2008
ClinicalTrials.gov Identifier:   NCT00135135
Health Authority:   United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
Cancer  
Childhood Tumor  
Neoplasms  

Study placed in the following topic categories:
Melphalan
Neuroectodermal Tumors, Primitive
Irinotecan
Carboplatin
Etoposide phosphate
Neuroblastoma
Doxorubicin
Neuroectodermal Tumors
Cisplatin
Neoplasms, Germ Cell and Embryonal
Isotretinoin
Tretinoin
Neuroepithelioma
Topotecan
Etoposide
Gefitinib
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Keratolytic Agents
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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