N2004-06: Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma
Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma, A Phase I Study
Sponsor: National Cancer Institute (NCI)
A observational or N/A phase clinical study on Neuroblastoma, this trial is completed. The trial is conducted by National Cancer Institute (NCI) and has accumulated 9 data snapshots since 2007. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)OBJECTIVES:
Primary
* To determine the maximum tolerated dose (MTD) of iodine I 131 metaiodobenzylguanidine when given in combination with fixed-dose irinotecan hydrochloride and vincristine in young patients with refractory or relapsed high-risk neuroblastoma.
* To determine the dose-limiting toxicities of iodine I 131 metaiodobenzylguanidine when combined with fixed-dose irinotecan hydrochloride and vincristine.
Secondary
* To determine if there is a therapeutic response to this regimen.
OUTLINE: This is a multicenter, dose-escalation study of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG).
Patients receive \^131I-MIBG IV over 1½-2 hours on day 1, vincristine IV on days 0 and 7, and irinotecan hydrochloride IV over 1 hour on days 0-4 and 7-11. Treatment repeats every 56 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.
OBJECTIVES:
Primary
* To determine the maximum tolerated dose (MTD) of iodine I 131 metaiodobenzylguanidine when given in combination with fixed-dose irinotecan hydrochloride and vincristine in young patients with refractory or relapsed high-risk neuroblastoma. * To determine the dose-limiting toxicities of iodine I 131 metaiodobenzylguanidine when combined with fixed-dose irinotecan hydrochloride and vincristine.
Secondary
* To determine if there is a therapeutic response to this regimen.
OUTLINE: This is a multicenter, dose-escalation study of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG).
Patients receive \^131I-MIBG IV over 1½-2 hours on day 1, vincristine IV on days 0 and 7, and irinotecan hydrochloride IV over 1 hour on days 0-4 and 7-11. Treatment repeats every 56 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.
Status Flow
Change History
9 versions recorded-
Apr 16, 2026 — Present [daily]
Completed
Phase: PHASE1 → None
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Sep 2024 — Apr 2026 [monthly]
Completed PHASE1
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
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Dec 2023 — Jul 2024 [monthly]
Completed PHASE1
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May 2023 — Dec 2023 [monthly]
Completed PHASE1
▶ Show 4 earlier versions
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Jan 2021 — May 2023 [monthly]
Completed PHASE1
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE1
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE1
First recorded
Jan 2007
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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.
Contact Information
- National Cancer Institute (NCI)
- New Approaches to Neuroblastoma Therapy Consortium
For direct contact, visit the study record on ClinicalTrials.gov .