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NCT00509353 · ClinicalTrials.gov registry record · Phase 1
N2004-06: Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma
A Phase 1 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00509353 is a Phase 1 study that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 26 participants.
The verdict
NCT00509353, a Phase 1 study, has completed, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIGB), may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as irinotecan and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving iodine I 131 MIGB together with irinotecan and vincristine may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of iodine I 131 MIGB when given together with irinotecan and vincristine in treating young patients with resistant or relapsed high-risk neuroblastoma.
Interventions
- DRUG irinotecan hydrochloride
- DRUG vincristine sulfate
- RADIATION iobenguane I 131
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2007-01 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00509353
The ClinicalTrials.gov registry entry for NCT00509353 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New Approaches to Neuroblastoma Therapy Consortium, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which irinotecan hydrochloride is the first listed.
NCT00509353 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00509353 about?
NCT00509353 is a clinical study titled "N2004-06: Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma". RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIGB), may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as irinotecan and vincristine, work in different ways to stop the growth of tumor cells, either by killing the ce...
What is the current status of trial NCT00509353?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2007-01. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00509353?
The interventions under investigation include: irinotecan hydrochloride (DRUG), vincristine sulfate (DRUG), iobenguane I 131 (RADIATION).
Who is sponsoring clinical trial NCT00509353?
This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 23 total clinical trials registered on ClinicalTrials.gov.
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