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| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 29, 2001 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00013806 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | CHP677: I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma: a Phase II Study |
| Official Title ICMJE | CHP677: I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma: a Phase II Study |
| Brief Summary | 131I-metaiodobenzylguanidine (131I-MIBG) is a norepinephrine analog that concentrates in adrenergic tissue and therefore holds promise for cell-specific treatment of neuroblastoma. This is a dual institution, Phase II study of 131I-MIBG administered at the previously defined maximum practical dose of 18 mCi/kg to children with relapsed or refractory neuroblastoma. |
| Detailed Description | |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment |
| Condition ICMJE | Neuroblastoma |
| Intervention ICMJE | Drug: 131I-MIBG |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion criteria: Refractory neuroblastoma with original diagnosis based on tumor histopathology or elevated urine VMA with typical tumor cells in the bone marrow. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00013806 |
| Responsible Party | |
| Study ID Numbers ICMJE | NCRR-M01RR00240-1748 |
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Center for Research Resources (NCRR) |
| Verification Date | December 2003 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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