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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 |
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 |
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 |
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.
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Show Detailed Description |
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |||||
St. Jude Children's Research Hospital | |||||
Memphis, Tennessee, United States, 38105 |
St. Jude Children's Research Hospital |
AstraZeneca |
National Institutes of Health (NIH) |
Principal Investigator: | Wayne L Furman, MD | St. Jude Children's Research Hospital |
St. Jude Children's Research Hospital 
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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 |
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