N2004-06: Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma
NCT00509353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2026-04-14
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.
Conditions
Interventions
- DRUG
-
irinotecan hydrochloride
- DRUG
-
vincristine sulfate
- RADIATION
-
iobenguane I 131
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
New Approaches to Neuroblastoma Therapy Consortium
lead OTHER
Principal Investigators
-
Steven DuBois, MD · UCSF Medical Center at Parnassus
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-01-31
- Primary Completion
- 2010-10-31
- Completion
- 2012-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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